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FDA 510(k)

NovoKnee (SteriKnee)

K-Number: K261032 · 2026-04-27

ApplicantNovoSource
Decision Date2026-04-27
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

NovoKnee (SteriKnee) is a medical device manufactured by NovoSource. It received FDA 510(k) clearance on 2026-04-27 under approval number K261032. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NovoKnee (SteriKnee)?

NovoKnee (SteriKnee) is a medical device that received FDA 510(k) clearance on 2026-04-27. It is manufactured by NovoSource. The 510(k) number is K261032.

When was NovoKnee (SteriKnee) approved by the FDA?

NovoKnee (SteriKnee) received FDA 510(k) clearance on 2026-04-27, under approval number K261032.

What company makes NovoKnee (SteriKnee)?

NovoKnee (SteriKnee) is manufactured by NovoSource.

What is the FDA product code for NovoKnee (SteriKnee)?

The FDA product code for NovoKnee (SteriKnee) is JWH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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