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FDA 510(k)

ENHANCED MODULAR AUSTIN MOORE HIP

K-Number: K936044 · 1994-04-26

ApplicantZimmer, Inc.
Decision Date1994-04-26
Product CodeKMC
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

ENHANCED MODULAR AUSTIN MOORE HIP is the device name listed in this FDA 510(k) record. The listed applicant is Zimmer, Inc.. It received FDA 510(k) clearance on 1994-04-26 under 510(k) number K936044. The device is classified under product code KMC. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENHANCED MODULAR AUSTIN MOORE HIP?

ENHANCED MODULAR AUSTIN MOORE HIP is a medical device that received FDA 510(k) clearance on 1994-04-26. The listed applicant is Zimmer, Inc.. The 510(k) number is K936044.

When did ENHANCED MODULAR AUSTIN MOORE HIP receive FDA 510(k) clearance?

ENHANCED MODULAR AUSTIN MOORE HIP received FDA 510(k) clearance on 1994-04-26, under 510(k) number K936044.

Who is the listed applicant for ENHANCED MODULAR AUSTIN MOORE HIP?

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 ENHANCED MODULAR AUSTIN MOORE HIP?

The FDA product code for ENHANCED MODULAR AUSTIN MOORE HIP is KMC.

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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: KMC)

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.

K853524APR REVISION HIP PROSTHESIS, FEMORAL COMPONENTIntermedics OrthopedicsK853259MALLORY/HEAD TOTAL HIP 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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