GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts
GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts (Massachusetts): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts. Its amount of 246 is above the median of 138 (79th percentile). Dated 55 days ago, it serves as a historical benchmark. Score 55/100. As of 2026-11-04, from U.S. FDA openFDA (510(k) clearances and device enforcement reports).
Data as of · Compiled by Zalwin from U.S. FDA openFDA (510(k) clearances and device enforcement reports)
amount: 246 · 79th percentile of 414 FDAPulse records · 1.8x the median
Free preview: all 14 published fields of this record are shown below. Locked: 40 related MA FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K260063 |
| Device | GSPE Spacer |
| Applicant | The General Hospital Corporation, d/b/a Massachusetts |
| Specialty / panel | Orthopedic |
| Product code | JWH |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-01-08 |
| Decision date | 2026-09-11 |
| Review time (days) | 246 |
| Third-party review | No |
| Applicant location | Somerville, MA, US |
| amount percentile | 79th of 414 (median 138, 1.8x median) |
| Peer records CSV (41 MA records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts
Free email alert. Alert me when this company gets a new filing, lien, permit, contract or expiry in this feed. One confirmation email; unsubscribe any time.
Free for 1 company. More companies from $9/mo (25), $49/mo (500 + CSV), $199/mo (500 + CSV + API). Cancel any time from the link in every email.
Unlock GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts + all 41 MA records (CSV)
Instant CSV download · Card, Apple Pay, Google Pay or Link via Stripe · No account required
CSV columns: Record · Specialty · Date · Review days · Recall class · official source URL
- Source agency: U.S. FDA openFDA (510(k) clearances and device enforcement reports)
- Record date: 2026-09-11
- Data refreshed: 2026-11-04
- Refunds on request within 14 days
Top FDAPulse records (MA first): Sensinel Cardiopulmonary Management (CPM) System (K260801) · multiFiltratePRO System (K261203) · a2z-Abdo-Triage (K260906) · BodyTom 64 (NL4100); OmniTom Elite (NL5000) (K261125) · Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Wed, 04 Nov 2026 09:16:12 GMT
Is this your business? Add a "Listed on Zalwin" badge to your site
Paste this snippet into your website. It links to this public record; nothing is tracked on your site.
Peer benchmark and outreach value: GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts and 41 Massachusetts peers
- Massachusetts FDAPulse records like this one: 41
- GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts's amount: 79th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Massachusetts peer: $8,200 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
55 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- A long 246-day review suggests additional-information requests: a firm likely to value regulatory help next time.
What is the FDAPulse record for GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts in Massachusetts?
GSPE Spacer (K260063) by The General Hospital Corporation, d/b/a Massachusetts was cleared on 2026-09-11 after 246 days of review.
How does GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts compare to other Massachusetts FDAPulse records?
Its amount of 246 sits in the upper half (79th percentile) of 414 records; the median is 138. It is 55 days old; check the official source for later updates before acting.
GSPE Spacer (K260063) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| GSPE Spacer (K260063) | MA | 2026-09-11 |
| TruVision Single-Use 1.9mm Arthroscopy System (K260156) | UT | 2026-10-09 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| F.A.S.T Screw (K254280) | FR | 2026-09-21 |
Related records
- TruVision Single-Use 1.9mm Arthroscopy System (K260156): 510(k) cleared for Nexus CMF, LLC
- Kentrospine Viktr-MIS® Pedicle screw system (K252139): 510(k) cleared for Rivarp Medical Pvt., Ltd.
- F.A.S.T Screw (K254280): 510(k) cleared for Steps Ortho
- The VEGA Cervical Screw System (K254260): 510(k) cleared for GS Medical Co., Ltd.
- AnyPlus II Spinal Fixation System (K261217): 510(k) cleared for GS Medical Co., Ltd.
- Freedom Nail Ankle Fusion System (K261189): 510(k) cleared for McGinley Orthopaedic Innovations
- APEX 3D S Diamond Tibia (K261120): 510(k) cleared for Paragon 28, Inc.
- Pediatric Nailing Platform Femur (K261345): 510(k) cleared for OrthoPediatrics Corp.
- DynaNail Helix® Fixation System (K260995): 510(k) cleared for MedShape, Inc.
- Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one ULTRABRAID Suture, Cobraid Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Blue; Q-FIX KNOTLESS All-Suture Anchor, 1.8mm, with one MINITAPE Suture, Co
- Tempo Plating System (K263407): 510(k) cleared for Pace Surgical
- Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc.
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Orthopedic devices
More Massachusetts public-record feeds
FEMA Hazard Mitigation Project Tracker in Massachusetts Nursing Home Inspection Deficiencies by State & Severity in Massachusetts Federal Alcohol Permit Holder Directory in Massachusetts New NIH Research Awards by Organization in Massachusetts New FDA Medical Device Listings by Manufacturer, CMO & Sterilizer in Massachusetts School & Library E-Rate Contracts Up for Rebid in Massachusetts New & Re-Approved E-Rate Service Providers (FCC Form 498 / SPIN) in Massachusetts New FDA PMA Device, NDA, Generic (ANDA), BLA & Drug Supplement Approvals by Sponsor in Massachusetts
How to monitor GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts and peer orthopedic records
Get new FDAPulse records like GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts by email (free, weekly)
We email one confirmation link now; the weekly digest starts only after you confirm. One-click unsubscribe in every email.
Double opt-in: nothing is sent until you click the confirmation link. One-click unsubscribe.
Get clearances and recalls like this every day
FDAPulse emails new 510(k) clearances and recalls for your specialties and competitors.
✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.
Often used together
- NPIPulse
- EPAPulse
- Municipal Public Works Prime Contract Operating Permit Renewal Pulse
- TrialRecruitmentPageAudit
- SubdomainShadowPulse
- MigrationSignalRadar
Or get the Healthcare Vendor Bundle for $14.99 one-time: Full CSV unlocks for group practices and FDA clearances/recalls.