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FDA 510(k)

COMPOSITE HITCH SUTURE ANCHOR

K-Number: K081172 · 2008-07-17

ApplicantBiomet Manufacturing Corp
Decision Date2008-07-17
Product CodeJDR
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

COMPOSITE HITCH SUTURE ANCHOR 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 2008-07-17 under 510(k) number K081172. The device is classified under product code JDR. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPOSITE HITCH SUTURE ANCHOR?

COMPOSITE HITCH SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2008-07-17. The listed applicant is Biomet Manufacturing Corp. The 510(k) number is K081172.

When did COMPOSITE HITCH SUTURE ANCHOR receive FDA 510(k) clearance?

COMPOSITE HITCH SUTURE ANCHOR received FDA 510(k) clearance on 2008-07-17, under 510(k) number K081172.

Who is the listed applicant for COMPOSITE HITCH SUTURE ANCHOR?

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 COMPOSITE HITCH SUTURE ANCHOR?

The FDA product code for COMPOSITE HITCH SUTURE ANCHOR is JDR.

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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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