FDA product code KIK: Hook, Bone
KIK is the FDA product code for hook, bone. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel. FDA has cleared 1 510(k) submission under KIK. The average 510(k) review took 4 days (median 4).
Classification
| Field | Value |
|---|---|
| Device name | Hook, Bone |
| Device class | Class I |
| Regulation | 21 CFR 878.4800 |
| Review panel | SU — General and Plastic Surgery |
| Medical specialty | General, Plastic Surgery |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KIK clearance
Top KIK applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Depuy, Inc. | 1 | 1977-04-29 |
Most recent KIK clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K770759 | Depuy, Inc. | HOOK HOLLER | 1977-04-29 | 4 |
Recalls for KIK devices
openFDA lists no recalls for product code KIK.
Frequently asked questions
What is FDA product code KIK?
KIK is the FDA product code for hook, bone. It is a Class I device, regulated under 21 CFR 878.4800 and reviewed by the General and Plastic Surgery panel.
What device class is KIK?
Class I, regulation 21 CFR 878.4800. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KIK?
Across 1 cleared submissions the average was 4 days from receipt to decision (median 4).
Which companies have the most KIK clearances?
Depuy, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KIK
- Run a recall and safety report across every KIK manufacturer
- Watch product code KIK 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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