Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC
Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC (Indiana): 510(k) cleared for Duet Spine Holdings, LLC. Its amount of 61 is below the median of 138 (18th percentile). Dated 35 days ago, it serves as a historical benchmark. Score 36/100. As of 2026-11-03, 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: 61 · 18th percentile of 414 FDAPulse records · 0.4x the median
Free preview: all 14 published fields of this record are shown below. Locked: 12 related IN FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K262712 |
| Device | Duet Spinal Fixation System |
| Applicant | Duet Spine Holdings, LLC |
| Specialty / panel | Orthopedic |
| Product code | NKB |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2026-07-31 |
| Decision date | 2026-09-30 |
| Review time (days) | 61 |
| Third-party review | No |
| Applicant location | Winona Lake, IN, US |
| amount percentile | 18th of 414 (median 138, 0.4x median) |
| Peer records CSV (13 IN records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC
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 Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings + all 13 IN 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: 2026-09-30
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (IN first): Kentrospine Viktr-MIS® Pedicle screw system (K252139) · Elecsys EBV EBNA IgG (K260221) · Elecsys EBV VCA IgG (K260232) · Elecsys EBV IgM (K260233) · Polymed TUR Irrigation Set, Single Spike, Tubing 90 with Lue · Browse all by state and category →
LIVE PUBLIC DATA Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) · Last refreshed: Tue, 03 Nov 2026 18:05:14 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: Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC and 13 Indiana peers
- Indiana FDAPulse records like this one: 13
- Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC's amount: 18th percentile of 414 records
- Timing: Low: older than 30 days
- Estimated pipeline if you contact every Indiana peer: $2,600 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
36 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 61-day review: this device is a strong predicate for similar products.
- Posted 35 days ago.
What is the FDAPulse record for Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC in Indiana?
Duet Spinal Fixation System (K262712) by Duet Spine Holdings, LLC was cleared on 2026-09-30 after 61 days of review.
How does Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC compare to other Indiana FDAPulse records?
Its amount of 61 is below the median (18th percentile); smaller records often move faster and face less competition. It is 35 days old, still within a typical 45-day follow-up window. Its Predicate Speed & CAPA Advisory Opportunity Score of 36/100 is modest; treat it as background rather than a priority.
Duet Spinal Fixation System (K262712) vs. top 2 peers
| Organization | Location | Record date |
|---|---|---|
| Duet Spinal Fixation System (K262712) | IN | 2026-09-30 |
| Kentrospine Viktr-MIS® Pedicle screw system (K252139) | IN | 2026-09-27 |
| Pediatric Nailing Platform Femur (K261345) | IN | 2026-09-24 |
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.
- GSPE Spacer (K260063): 510(k) cleared for The General Hospital Corporation, d/b/a Massachusetts
- 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
Recent FDA 510(k) clearances FDA 510(k) clearances and recalls: Orthopedic devices
More Indiana public-record feeds
FEMA Hazard Mitigation Project Tracker in Indiana New MSHA Citations at Mines & Quarries by State in Indiana FMCSA Trucking Insurance Cancellations by Carrier, Insurer & Fleet Size in Indiana New FDA Medical Device Listings by Manufacturer, CMO & Sterilizer in Indiana SEC 8-K Corporate Trigger Events in Indiana New Grants by Vendor Procurement Need in Indiana HIPAA Breach Reports (500+ Individuals) by State & Type in Indiana New & Re-Approved E-Rate Service Providers (FCC Form 498 / SPIN) in Indiana
How to monitor Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC and peer orthopedic records
Get new FDAPulse records like Duet Spinal Fixation System (K262712): 510(k) cleared for Duet Spine Holdings, LLC 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.