FDA 510(k)

OPTIFIX ABSORBABLE FIXATION SYSTEM

K-Number: K132134 · 2013-12-02

Decision Date2013-12-02

Product CodeGDW

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

OPTIFIX ABSORBABLE FIXATION SYSTEM 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 2013-12-02 under 510(k) number K132134. 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 ABSORBABLE FIXATION SYSTEM?

OPTIFIX ABSORBABLE FIXATION SYSTEM is a medical device that received FDA 510(k) clearance on 2013-12-02. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K132134.

When did OPTIFIX ABSORBABLE FIXATION SYSTEM receive FDA 510(k) clearance?

OPTIFIX ABSORBABLE FIXATION SYSTEM received FDA 510(k) clearance on 2013-12-02, under 510(k) number K132134.

Who is the listed applicant for OPTIFIX ABSORBABLE FIXATION SYSTEM?

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 ABSORBABLE FIXATION SYSTEM?

The FDA product code for OPTIFIX ABSORBABLE FIXATION SYSTEM is GDW.

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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.