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FDA 510(k)

DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H

K-Number: K042966 · 2004-11-19

ApplicantLinvatec Biomaterials, Ltd.
Decision Date2004-11-19
Product CodeMAI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H is the device name listed in this FDA 510(k) record. The listed applicant is Linvatec Biomaterials, Ltd.. It received FDA 510(k) clearance on 2004-11-19 under 510(k) number K042966. The device is classified under product code MAI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H?

DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H is a medical device that received FDA 510(k) clearance on 2004-11-19. The listed applicant is Linvatec Biomaterials, Ltd.. The 510(k) number is K042966.

When did DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H receive FDA 510(k) clearance?

DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H received FDA 510(k) clearance on 2004-11-19, under 510(k) number K042966.

Who is the listed applicant for DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H?

The FDA 510(k) record lists Linvatec Biomaterials, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H?

The FDA product code for DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H is MAI.

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Other records listing Linvatec Biomaterials, Ltd. as applicant

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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