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FDA 510(k)

EXTREMITY MEDICAL SUTURE ANCHOR

K-Number: K083151 · 2009-01-22

ApplicantExtremity Medical, LLC
Decision Date2009-01-22
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

EXTREMITY MEDICAL SUTURE ANCHOR is the device name listed in this FDA 510(k) record. The listed applicant is Extremity Medical, LLC. It received FDA 510(k) clearance on 2009-01-22 under 510(k) number K083151. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EXTREMITY MEDICAL SUTURE ANCHOR?

EXTREMITY MEDICAL SUTURE ANCHOR is a medical device that received FDA 510(k) clearance on 2009-01-22. The listed applicant is Extremity Medical, LLC. The 510(k) number is K083151.

When did EXTREMITY MEDICAL SUTURE ANCHOR receive FDA 510(k) clearance?

EXTREMITY MEDICAL SUTURE ANCHOR received FDA 510(k) clearance on 2009-01-22, under 510(k) number K083151.

Who is the listed applicant for EXTREMITY MEDICAL SUTURE ANCHOR?

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

What is the FDA product code for EXTREMITY MEDICAL SUTURE ANCHOR?

The FDA product code for EXTREMITY MEDICAL SUTURE ANCHOR is MBI.

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Other records listing Extremity Medical, LLC 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.

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Related Devices (Code: MBI)

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.

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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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