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FDA 510(k)

Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER

K-Number: K132513 · 2013-09-19

ApplicantArthroCare Corporation
Decision Date2013-09-19
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER is the device name listed in this FDA 510(k) record. The listed applicant is ArthroCare Corporation. It received FDA 510(k) clearance on 2013-09-19 under 510(k) number K132513. 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 Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER?

Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER is a medical device that received FDA 510(k) clearance on 2013-09-19. The listed applicant is ArthroCare Corporation. The 510(k) number is K132513.

When did Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER receive FDA 510(k) clearance?

Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER received FDA 510(k) clearance on 2013-09-19, under 510(k) number K132513.

Who is the listed applicant for Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER?

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

What is the FDA product code for Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER?

The FDA product code for Q-FIX SUTURE ANCHOR,1.8MM AND 2.8MM / DRILL, DRILL GUIDE AND OBTURATOR,1.8MM AND 2.8MM /BONE PUNCH,2.8MM AND KNOT PUSHER 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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