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FDA 510(k)

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners

K-Number: K191287 · 2019-07-16

ApplicantDavol Inc., Subsidiary of C.R. Bard
Decision Date2019-07-16
Product CodeGDW
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners is the device name listed in this FDA 510(k) record. The listed applicant is Davol Inc., Subsidiary of C.R. Bard. It received FDA 510(k) clearance on 2019-07-16 under 510(k) number K191287. 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 AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners?

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners is a medical device that received FDA 510(k) clearance on 2019-07-16. The listed applicant is Davol Inc., Subsidiary of C.R. Bard. The 510(k) number is K191287.

When did OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners receive FDA 510(k) clearance?

OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners received FDA 510(k) clearance on 2019-07-16, under 510(k) number K191287.

Who is the listed applicant for OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners?

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

What is the FDA product code for OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners?

The FDA product code for OptiFix AT Absorbable Fixation System with Articulating Technology – 30 Fasteners, OptiFix AT Absorbable Fixation System with Articulating Technology – 15 Fasteners is GDW.

Other records listing Davol Inc., Subsidiary of C.R. Bard as applicant

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Official Source

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