FDA product code KWK: Appliance, Nail/Blade/Plate Combination, Single Component

KWK is the FDA product code for appliance, nail/blade/plate combination, single component. 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 KWK. The average 510(k) review took 365 days (median 365).

Classification

Compare with all 510(k) review times · Search every KWK clearance

Top KWK applicants

Most recent KWK clearances

Recalls for KWK devices

openFDA lists no recalls for product code KWK.

Frequently asked questions

What is FDA product code KWK?

KWK is the FDA product code for appliance, nail/blade/plate combination, single component. It is a Class II device, regulated under 21 CFR 888.3030 and reviewed by the Orthopedic panel.

What device class is KWK?

Class II, regulation 21 CFR 888.3030. Typical premarket route: 510(k).

How long does a 510(k) take for product code KWK?

Across 1 cleared submissions the average was 365 days from receipt to decision (median 365).

Which companies have the most KWK clearances?

Onyx Medical Corp. (1).

Next steps

• Run an FDA pathway report with predicate devices for product code KWK
• Run a recall and safety report across every KWK manufacturer
• Watch product code KWK 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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