FDA 510(k)

RECLAIM Monobloc Revision Femoral Stem

K-Number: K251292 · 2025-05-23

Decision Date2025-05-23

Product CodeLZO

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

RECLAIM Monobloc Revision Femoral Stem is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2025-05-23 under approval number K251292. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RECLAIM Monobloc Revision Femoral Stem?

RECLAIM Monobloc Revision Femoral Stem is a medical device that received FDA 510(k) clearance on 2025-05-23. It is manufactured by Depuy Ireland UC. The 510(k) number is K251292.

When was RECLAIM Monobloc Revision Femoral Stem approved by the FDA?

RECLAIM Monobloc Revision Femoral Stem received FDA 510(k) clearance on 2025-05-23, under approval number K251292.

What company makes RECLAIM Monobloc Revision Femoral Stem?

RECLAIM Monobloc Revision Femoral Stem is manufactured by Depuy Ireland UC.

What is the FDA product code for RECLAIM Monobloc Revision Femoral Stem?

The FDA product code for RECLAIM Monobloc Revision Femoral Stem is LZO.

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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.