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FDA 510(k)

Arthrex 3.5 mm Locking Compression Plates

K-Number: K222244 · 2022-09-30

ApplicantArthrex, Inc.
Decision Date2022-09-30
Product CodeHRS
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arthrex 3.5 mm Locking Compression Plates is a medical device manufactured by Arthrex, Inc.. It received FDA 510(k) clearance on 2022-09-30 under approval number K222244. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arthrex 3.5 mm Locking Compression Plates?

Arthrex 3.5 mm Locking Compression Plates is a medical device that received FDA 510(k) clearance on 2022-09-30. It is manufactured by Arthrex, Inc.. The 510(k) number is K222244.

When was Arthrex 3.5 mm Locking Compression Plates approved by the FDA?

Arthrex 3.5 mm Locking Compression Plates received FDA 510(k) clearance on 2022-09-30, under approval number K222244.

What company makes Arthrex 3.5 mm Locking Compression Plates?

Arthrex 3.5 mm Locking Compression Plates is manufactured by Arthrex, Inc..

What is the FDA product code for Arthrex 3.5 mm Locking Compression Plates?

The FDA product code for Arthrex 3.5 mm Locking Compression Plates is HRS.

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Official Source

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