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FDA 510(k)

HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS

K-Number: K953510 · 1995-08-09

ApplicantEncore Orthopedics, Inc.
Decision Date1995-08-09
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS 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 1995-08-09 under 510(k) number K953510. 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 HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS?

HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS is a medical device that received FDA 510(k) clearance on 1995-08-09. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K953510.

When did HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS receive FDA 510(k) clearance?

HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS received FDA 510(k) clearance on 1995-08-09, under 510(k) number K953510.

Who is the listed applicant for HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS?

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 HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS?

The FDA product code for HIP JOINT FEMORAL (HEMI-HIP) METAL/POLYMER CEMENTED OR UNCEMENTED PROSTHESIS is KWY.

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Official Source

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

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