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FDA 510(k)

ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD

K-Number: K944601 · 1995-01-12

ApplicantZimmer, Inc.
Decision Date1995-01-12
Product CodeLZO
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1995-01-12 under 510(k) number K944601. 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 ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD?

ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD is a medical device that received FDA 510(k) clearance on 1995-01-12. The listed applicant is Zimmer, Inc.. The 510(k) number is K944601.

When did ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD receive FDA 510(k) clearance?

ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD received FDA 510(k) clearance on 1995-01-12, under 510(k) number K944601.

Who is the listed applicant for ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD?

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

What is the FDA product code for ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD?

The FDA product code for ZIMMER ZIRCONIA CERAMIC FEMORAL HEAD is LZO.

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Other records listing Zimmer, 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.

K262955OsseoFit Stemless Shoulder SystemK260831Z1 Hip SystemK261683Augment Off-Axis Instrument SystemK251840Zimmer® Persona® Personalized Knee SystemK260182Avenir® Müller Stem; Avenir Complete™ Hip SystemK253592Zimmer Biomet Reverse Shoulder Prosthesis (Alliance Humeral Bearings, Identity Humeral Trays, Comprehensive Reverse Humeral Trays, Comprehensive Reverse 32mm Glenospheres and Adapter)

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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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