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FDA 510(k)

POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE

K-Number: K130467 · 2013-12-05

ApplicantMedShape, Inc.
Decision Date2013-12-05
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE is the device name listed in this FDA 510(k) record. The listed applicant is MedShape, Inc.. It received FDA 510(k) clearance on 2013-12-05 under 510(k) number K130467. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE?

POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE is a medical device that received FDA 510(k) clearance on 2013-12-05. The listed applicant is MedShape, Inc.. The 510(k) number is K130467.

When did POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE receive FDA 510(k) clearance?

POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE received FDA 510(k) clearance on 2013-12-05, under 510(k) number K130467.

Who is the listed applicant for POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE?

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

What is the FDA product code for POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE?

The FDA product code for POROUS MORPHIX SUTURE ANCHOR WITH FORCE FIBER SUTURE is MBI.

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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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