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FDA 510(k)

APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W

K-Number: K122463 · 2012-10-11

ApplicantCayenne Medical, Inc.
Decision Date2012-10-11
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W is the device name listed in this FDA 510(k) record. The listed applicant is Cayenne Medical, Inc.. It received FDA 510(k) clearance on 2012-10-11 under 510(k) number K122463. 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 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W?

APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W is a medical device that received FDA 510(k) clearance on 2012-10-11. The listed applicant is Cayenne Medical, Inc.. The 510(k) number is K122463.

When did APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W receive FDA 510(k) clearance?

APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W received FDA 510(k) clearance on 2012-10-11, under 510(k) number K122463.

Who is the listed applicant for APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W?

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

What is the FDA product code for APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W?

The FDA product code for APERFIX AM FEMORAL IMPLANT WITH INSERTER, 9X24 APERFIX AM FEMORAL IMPLANT WITH INSERTER, 10X24 APERFIX FEMORAL IMPLANT W 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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