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FDA 510(k)

FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES

K-Number: K973614 · 1997-12-18

ApplicantEncore Orthopedics, Inc.
Decision Date1997-12-18
Product CodeKWL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES is the device name listed in this FDA 510(k) record. The listed applicant is Encore Orthopedics, Inc.. It received FDA 510(k) clearance on 1997-12-18 under 510(k) number K973614. The device is classified under product code KWL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES?

FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES is a medical device that received FDA 510(k) clearance on 1997-12-18. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K973614.

When did FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES receive FDA 510(k) clearance?

FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES received FDA 510(k) clearance on 1997-12-18, under 510(k) number K973614.

Who is the listed applicant for FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES?

The FDA 510(k) record lists Encore Orthopedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES?

The FDA product code for FOUNDATION UNIPOLAR FEMORAL HEAD WITH MODULAR NECK LENGTH SLEEVES is KWL.

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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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