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FDA 510(k)

INTEGRAL TOTAL HIP SYSTEM

K-Number: K921225 · 1994-02-16

ApplicantBiomet, Inc.
Decision Date1994-02-16
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

INTEGRAL TOTAL HIP SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1994-02-16 under 510(k) number K921225. The device is classified under product code LZO. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTEGRAL TOTAL HIP SYSTEM?

INTEGRAL TOTAL HIP SYSTEM is a medical device that received FDA 510(k) clearance on 1994-02-16. The listed applicant is Biomet, Inc.. The 510(k) number is K921225.

When did INTEGRAL TOTAL HIP SYSTEM receive FDA 510(k) clearance?

INTEGRAL TOTAL HIP SYSTEM received FDA 510(k) clearance on 1994-02-16, under 510(k) number K921225.

Who is the listed applicant for INTEGRAL TOTAL HIP SYSTEM?

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

What is the FDA product code for INTEGRAL TOTAL HIP SYSTEM?

The FDA product code for INTEGRAL TOTAL HIP SYSTEM is LZO.

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Other records listing Biomet, 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.

K253434OSSTM Orthopedic Salvage SystemK251270Taperloc® Complete Hip StemK241014Biomet Kirschner Wires (K-Wires)K222760StageOne™ Select Hip Cement Spacer MoldsK221968StageOne™ Shoulder Cement Spacer MoldsK213287StageOne Knee Cement Spacer Molds

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Related Devices (Code: LZO)

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.

K260173M-Vizion Femoral Revision System ExtensionMedacta International S.A.K253948Momentum Acetabular Cup SystemUnited Orthopedic CorporationK261009MobileLink Acetabular Cup System – 40mm ID Inserts (various)Waldemar Link GmbH & Co. KGK260831Z1 Hip SystemZimmer, Inc.K260182Avenir® Müller Stem; Avenir Complete™ Hip SystemZimmer, Inc.K260037implantcast Packaging System UpdateImplantcast GmbH

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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