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FDA 510(k)

ADVANTAGE MAPF HIP FEMORAL COMPONENT

K-Number: K960643 · 1996-12-16

ApplicantBiomet, Inc.
Decision Date1996-12-16
Product CodeKWY
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ADVANTAGE MAPF HIP FEMORAL COMPONENT is the device name listed in this FDA 510(k) record. The listed applicant is Biomet, Inc.. It received FDA 510(k) clearance on 1996-12-16 under 510(k) number K960643. 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 ADVANTAGE MAPF HIP FEMORAL COMPONENT?

ADVANTAGE MAPF HIP FEMORAL COMPONENT is a medical device that received FDA 510(k) clearance on 1996-12-16. The listed applicant is Biomet, Inc.. The 510(k) number is K960643.

When did ADVANTAGE MAPF HIP FEMORAL COMPONENT receive FDA 510(k) clearance?

ADVANTAGE MAPF HIP FEMORAL COMPONENT received FDA 510(k) clearance on 1996-12-16, under 510(k) number K960643.

Who is the listed applicant for ADVANTAGE MAPF HIP FEMORAL COMPONENT?

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 ADVANTAGE MAPF HIP FEMORAL COMPONENT?

The FDA product code for ADVANTAGE MAPF HIP FEMORAL COMPONENT is KWY.

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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: KWY)

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.

K253357b-ONE® Bipolar HeadB-One Ortho, Corp.K243634Maxx Libertas Bipolar Hip Head (Bipolar Hip)Maxx Orthopedics, Inc.K231526CORAIL Cemented Femoral StemDepuy Ireland UCK223441SpaceFlex Acetabular CupG21, S.R.L.K221794Vario-Cup SystemWaldemar Link GmbH & Co. KGK220492COPAL exchange G hip spacerHeraeus Medical 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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