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FDA 510(k)

METAL BACKED ACETABULAR COMPONENT

K-Number: K950542 · 1995-05-25

ApplicantEncore Orthopedics, Inc.
Decision Date1995-05-25
Product CodeJDL
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

METAL BACKED ACETABULAR COMPONENT 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 1995-05-25 under 510(k) number K950542. The device is classified under product code JDL. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the METAL BACKED ACETABULAR COMPONENT?

METAL BACKED ACETABULAR COMPONENT is a medical device that received FDA 510(k) clearance on 1995-05-25. The listed applicant is Encore Orthopedics, Inc.. The 510(k) number is K950542.

When did METAL BACKED ACETABULAR COMPONENT receive FDA 510(k) clearance?

METAL BACKED ACETABULAR COMPONENT received FDA 510(k) clearance on 1995-05-25, under 510(k) number K950542.

Who is the listed applicant for METAL BACKED ACETABULAR COMPONENT?

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 METAL BACKED ACETABULAR COMPONENT?

The FDA product code for METAL BACKED ACETABULAR COMPONENT is JDL.

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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: JDL)

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.

K073499VERSYS EPOCH FULLCOAT HIP PROSTHESIS, MODEL 4088 SERIESZimmer, Inc.K070785DYNASTY ACETABULAR SYSTEMWrightmedicaltechnologyincK061844DYNASTY ACETABULAR SHELL AND COCR ACETABULAR LINERWrightmedicaltechnologyincK051995PROFEMUR RENAISSANCE HIP STEMWrightmedicaltechnologyincK051348CONSERVE TOTAL FEMORAL HEADWrightmedicaltechnologyincK042841M2A/C2A ACETABULAR SYSTEMBiomet, Inc.

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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