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FDA 510(k)

CORAIL Cemented Femoral Stem

K-Number: K231526 · 2023-12-19

ApplicantDepuy Ireland UC
Decision Date2023-12-19
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

CORAIL Cemented Femoral Stem is a medical device manufactured by Depuy Ireland UC. It received FDA 510(k) clearance on 2023-12-19 under approval number K231526. The device is classified under product code KWY. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CORAIL Cemented Femoral Stem?

CORAIL Cemented Femoral Stem is a medical device that received FDA 510(k) clearance on 2023-12-19. It is manufactured by Depuy Ireland UC. The 510(k) number is K231526.

When was CORAIL Cemented Femoral Stem approved by the FDA?

CORAIL Cemented Femoral Stem received FDA 510(k) clearance on 2023-12-19, under approval number K231526.

What company makes CORAIL Cemented Femoral Stem?

CORAIL Cemented Femoral Stem is manufactured by Depuy Ireland UC.

What is the FDA product code for CORAIL Cemented Femoral Stem?

The FDA product code for CORAIL Cemented Femoral Stem is KWY.

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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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