FDA product code NOV: Anchor, Suture, Bone Fixation, Metallic
NOV is the FDA product code for anchor, suture, bone fixation, metallic. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel. FDA has cleared 1 510(k) submission under NOV. The average 510(k) review took 49 days (median 49). FDA has posted 1 recall for NOV devices.
Definition
This device is indicated for attaching suture into bone for suspension of the nasal valve and for attaching suture into bone at the lower orbital rim.
Classification
| Field | Value |
|---|---|
| Device name | Anchor, Suture, Bone Fixation, Metallic |
| Device class | Class II |
| Regulation | 21 CFR 888.3030 |
| Review panel | OR — Orthopedic |
| Medical specialty | Orthopedic |
| Premarket route | 510(k) |
| Implant | Yes |
Compare with all 510(k) review times · Search every NOV clearance
Top NOV applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Mitek Worldwide | 1 | 2003-08-25 |
Most recent NOV clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K032078 | Mitek Worldwide | MITEK MICRO QUICKANCHOR | 2003-08-25 | 49 |
Recalls for NOV devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2016-06-17.
Frequently asked questions
What is FDA product code NOV?
NOV is the FDA product code for anchor, suture, bone fixation, metallic. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.
What device class is NOV?
Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).
How long does a 510(k) take for product code NOV?
Across 1 cleared submissions the average was 49 days from receipt to decision (median 49).
Which companies have the most NOV clearances?
Mitek Worldwide (1).
Have NOV devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2016-06-17.
Next steps
- Run an FDA pathway report with predicate devices for product code NOV
- Run a recall and safety report across every NOV manufacturer
- Watch product code NOV 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.
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