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FDA 510(k)

FMP METAL/METAL ACETABULAR INSERT

K-Number: K003250 · 2001-01-25

ApplicantEncore Orthopedics, Inc.
Decision Date2001-01-25
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

FMP METAL/METAL ACETABULAR INSERT 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 2001-01-25 under 510(k) number K003250. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FMP METAL/METAL ACETABULAR INSERT?

FMP METAL/METAL ACETABULAR INSERT is a medical device that received FDA 510(k) clearance on 2001-01-25. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K003250.

When did FMP METAL/METAL ACETABULAR INSERT receive FDA 510(k) clearance?

FMP METAL/METAL ACETABULAR INSERT received FDA 510(k) clearance on 2001-01-25, under 510(k) number K003250.

Who is the listed applicant for FMP METAL/METAL ACETABULAR INSERT?

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 FMP METAL/METAL ACETABULAR INSERT?

The FDA product code for FMP METAL/METAL ACETABULAR INSERT is KWA.

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Other records listing Encore Orthopedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K0329053DKNEE POROUS COATED FEMORAL COMPONENTK0201143D KNEEK020741UNICONDYLAR KNEEK020236MODIFICATION TO PASS SPINAL SYSTEMK020170KEYSTONE HIP SYSTEM CALCAR REPLACEMENT BODY AND BUILD UPK013490CEMENTED CALCAR HIP SYSTEM

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Related Devices (Code: KWA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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