FDA 510(k)

5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL

K-Number: K110164 · 2011-02-07

Decision Date2011-02-07

Product CodeMBI

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL is the device name listed in this FDA 510(k) record. The listed applicant is Arthrocare Corp.. It received FDA 510(k) clearance on 2011-02-07 under 510(k) number K110164. 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 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL?

5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL is a medical device that received FDA 510(k) clearance on 2011-02-07. The listed applicant is Arthrocare Corp.. The 510(k) number is K110164.

When did 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL receive FDA 510(k) clearance?

5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL received FDA 510(k) clearance on 2011-02-07, under 510(k) number K110164.

Who is the listed applicant for 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL?

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

What is the FDA product code for 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL?

The FDA product code for 5.5MM SPARTAN PEEK SUTURE IMPLANT W/ #2 MAGNUM WIRE, PUNCH TAP, EXTRACTION TOOL 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.