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FDA 510(k)

COMPRESS ANTI-ROTATION SPINDLES

K-Number: K101475 · 2010-06-18

ApplicantBiomet Manufacturing Corp
Decision Date2010-06-18
Product CodeKWA
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPRESS ANTI-ROTATION SPINDLES is the device name listed in this FDA 510(k) record. The listed applicant is Biomet Manufacturing Corp. It received FDA 510(k) clearance on 2010-06-18 under 510(k) number K101475. The device is classified under product code KWA. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPRESS ANTI-ROTATION SPINDLES?

COMPRESS ANTI-ROTATION SPINDLES is a medical device that received FDA 510(k) clearance on 2010-06-18. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K101475.

When did COMPRESS ANTI-ROTATION SPINDLES receive FDA 510(k) clearance?

COMPRESS ANTI-ROTATION SPINDLES received FDA 510(k) clearance on 2010-06-18, under 510(k) number K101475.

Who is the listed applicant for COMPRESS ANTI-ROTATION SPINDLES?

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

What is the FDA product code for COMPRESS ANTI-ROTATION SPINDLES?

The FDA product code for COMPRESS ANTI-ROTATION SPINDLES is KWA.

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Related Devices (Code: KWA)

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.

K122778PROFEMUR Z REVISION HIP STEMWrightmedicaltechnologyincK121544DYNASTY BIOFOAM SHELLWrightmedicaltechnologyincK113271METAL-ON-METAL HIP SYSTEMS-ADDITIONAL CONTRAINDICATIONSBiomet Manufacturing, Inc.K113322CONSERVE THIN SHELLWrightmedicaltechnologyincK112080PRESERVE HIP STEMWrightmedicaltechnologyincK112150PROFEMUR GLADIATOR HA HIP STEMWrightmedicaltechnologyinc

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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