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FDA 510(k)

OptiFix Open Absorbable Fixation System - 20 absorbable fasteners

K-Number: K163698 · 2017-04-11

ApplicantC.R. Bard, Inc.
Decision Date2017-04-11
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

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

When was OptiFix Open Absorbable Fixation System - 20 absorbable fasteners approved by the FDA?

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

What company makes OptiFix Open Absorbable Fixation System - 20 absorbable fasteners?

OptiFix Open Absorbable Fixation System - 20 absorbable fasteners is manufactured by C.R. Bard, Inc..

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.

Related Clinical Trials

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Related PubMed Literature

PMID: 42168293 Comparative in vitro and in vivo assessment of three experimental extracellular matrix meshes for soft tissue remodeling. Scientific reports (2026)

Other Devices by C.R. Bard, Inc.

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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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