Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc.
Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc. (North Carolina): 510(k) cleared for restor3d, inc. Its amount of 27 is below the median of 138 (3rd percentile). Dated 13 days ago, it is in the active follow-up window. Score 47/100. 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: 27 · 3th percentile of 414 FDAPulse records · 0.2x the median
Free preview: all 14 published fields of this record are shown below. Locked: 8 related NC FDAPulse records and the 5-column CSV export.
| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K263421 |
| Device | Veritas Shoulder System |
| Applicant | restor3d, inc. |
| Specialty / panel | Orthopedic |
| Product code | PHX |
| Device class | 2 |
| Clearance type | Special |
| Decision | Substantially Equivalent |
| Received | 2026-09-25 |
| Decision date | 2026-10-22 |
| Review time (days) | 27 |
| Third-party review | No |
| Applicant location | Durham, NC, US |
| amount percentile | 3th of 414 (median 138, 0.2x median) |
| Peer records CSV (9 NC records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
Watch Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc.
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 Veritas Shoulder System (K263421): 510(k) cleared for restor3d + all 9 NC 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: 2026-10-22
- Data refreshed: 2026-11-03
- Refunds on request within 14 days
Top FDAPulse records (NC first): EzSensor HD (K261663) · FINDER Flu A&B/SARS-CoV-2 Test (K261837) · Endox Test Strips (K263267) · SAS MIS Pelvic Incidence Rods (K263172) · Class II recall Z-0200-2027 · 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: Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc. and 9 North Carolina peers
- North Carolina FDAPulse records like this one: 9
- Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc.'s amount: 3rd percentile of 414 records
- Timing: Medium: dated in the last 30 days
- Estimated pipeline if you contact every North Carolina peer: $1,800 (peers × rate × deal size; an estimate from your assumptions, not a forecast)
47 / 100 Predicate Speed & CAPA Advisory Opportunity Score
- Fast 27-day review: this device is a strong predicate for similar products.
- Special 510(k): a modification of an existing device.
- Posted 13 days ago.
What is the FDAPulse record for Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc. in North Carolina?
Veritas Shoulder System (K263421) by restor3d, inc. was cleared on 2026-10-22 after 27 days of review.
How does Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc. compare to other North Carolina FDAPulse records?
Its amount of 27 is below the median (3th percentile); smaller records often move faster and face less competition. It is fresh: dated 13 days ago, inside the window where early outreach matters most.
Veritas Shoulder System (K263421) vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Veritas Shoulder System (K263421) | NC | 2026-10-22 |
| 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.
- 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 North Carolina public-record feeds
CMS HAC Reduction & Readmissions Penalties by Hospital in North Carolina New NSF Research Awards by Institution in North Carolina New Trucking Company Registrations in North Carolina New NIH Research Awards by Organization in North Carolina SEC 8-K Corporate Trigger Events in North Carolina New Health-Based Drinking Water Violations by Water System (EPA SDWIS) in North Carolina Excluded Health Care Business Search (OIG LEIE) in North Carolina Credit Union Quarterly Changes, Mergers & New Charters (NCUA Call Reports) in North Carolina
How to monitor Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc. and peer orthopedic records
Get new FDAPulse records like Veritas Shoulder System (K263421): 510(k) cleared for restor3d, inc. 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.