FDA product code OVZ: Pin, Fixation, Resorbable, Hard Tissue
OVZ is the FDA product code for pin, fixation, resorbable, hard tissue. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel. FDA has cleared 3 510(k) submissions under OVZ, from 3 different applicants. The average 510(k) review took 88 days (median 85).
Definition
Intended for small bone fixation in fracture, osteotomy, and arthrodesis applications.
Classification
| Field | Value |
|---|---|
| Device name | Pin, Fixation, Resorbable, Hard Tissue |
| Device class | Class II |
| Regulation | 21 CFR 888.3040 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every OVZ clearance
Top OVZ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Biomet, Inc. | 1 | 2014-04-18 |
| DePuy Orthopaedics, Inc. | 1 | 2011-07-12 |
| Johnson & Johnson International | 1 | 1990-08-15 |
Most recent OVZ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K140625 | Biomet, Inc. | ORTHOSORB LS | 2014-04-18 | 38 |
| K111077 | DePuy Orthopaedics, Inc. | ORTHOSORB RESORBABLE PINS | 2011-07-12 | 85 |
| K901456 | Johnson & Johnson International | ORTHOSORB(R) ABSORBABLE PIN | 1990-08-15 | 141 |
Recalls for OVZ devices
openFDA lists no recalls for product code OVZ.
Frequently asked questions
What is FDA product code OVZ?
OVZ is the FDA product code for pin, fixation, resorbable, hard tissue. It is a Class II device, regulated under 21 CFR 888.3040 and reviewed by the Orthopedic panel.
What device class is OVZ?
Class II, regulation 21 CFR 888.3040. Typical premarket route: 510(k).
How long does a 510(k) take for product code OVZ?
Across 3 cleared submissions the average was 88 days from receipt to decision (median 85).
Which companies have the most OVZ clearances?
Biomet, Inc. (1); DePuy Orthopaedics, Inc. (1); Johnson & Johnson International (1).
Next steps
- Run an FDA pathway report with predicate devices for product code OVZ
- Run a recall and safety report across every OVZ manufacturer
- Watch product code OVZ for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Orthopedic product codes · FDA product code lookup · 510(k) database search · 510(k) review times