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FDA 510(k)

REGENEREX POROUS TITANIUM SLEEVE AUGMENTS

K-Number: K072336 · 2007-11-05

ApplicantBiomet Manufacturing Corp
Decision Date2007-11-05
Product CodeJWH
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

REGENEREX POROUS TITANIUM SLEEVE AUGMENTS 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 2007-11-05 under 510(k) number K072336. The device is classified under product code JWH. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REGENEREX POROUS TITANIUM SLEEVE AUGMENTS?

REGENEREX POROUS TITANIUM SLEEVE AUGMENTS is a medical device that received FDA 510(k) clearance on 2007-11-05. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K072336.

When did REGENEREX POROUS TITANIUM SLEEVE AUGMENTS receive FDA 510(k) clearance?

REGENEREX POROUS TITANIUM SLEEVE AUGMENTS received FDA 510(k) clearance on 2007-11-05, under 510(k) number K072336.

Who is the listed applicant for REGENEREX POROUS TITANIUM SLEEVE AUGMENTS?

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 REGENEREX POROUS TITANIUM SLEEVE AUGMENTS?

The FDA product code for REGENEREX POROUS TITANIUM SLEEVE AUGMENTS is JWH.

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Related Devices (Code: JWH)

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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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