FDA 510(k)

OptiFix Open Absorbable Fixation System - 20 absorbable fasteners

K-Number: K163698 · 2017-04-11

Decision Date2017-04-11

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OptiFix Open Absorbable Fixation System - 20 absorbable fasteners is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2017-04-11 under 510(k) number K163698. The device is classified under product code GDW. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiFix Open Absorbable Fixation System - 20 absorbable fasteners?

OptiFix Open Absorbable Fixation System - 20 absorbable fasteners is a medical device that received FDA 510(k) clearance on 2017-04-11. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K163698.

When did OptiFix Open Absorbable Fixation System - 20 absorbable fasteners receive FDA 510(k) clearance?

OptiFix Open Absorbable Fixation System - 20 absorbable fasteners received FDA 510(k) clearance on 2017-04-11, under 510(k) number K163698.

Who is the listed applicant for OptiFix Open Absorbable Fixation System - 20 absorbable fasteners?

The FDA 510(k) record lists C.R. Bard, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiFix Open Absorbable Fixation System - 20 absorbable fasteners?

The FDA product code for OptiFix Open Absorbable Fixation System - 20 absorbable fasteners is GDW.

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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.