FDA 510(k)

SYNTHES SYNCAGE EVOLUTION SPACER

K-Number: K122639 · 2013-05-24

Decision Date2013-05-24

Product CodeMAX

Advisory CommitteeOR

DecisionSubstantially Equivalent

Device Summary

SYNTHES SYNCAGE EVOLUTION SPACER is the device name listed in this FDA 510(k) record. The listed applicant is Synthes (USA) Products, LLC. It received FDA 510(k) clearance on 2013-05-24 under 510(k) number K122639. The device is classified under product code MAX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYNTHES SYNCAGE EVOLUTION SPACER?

SYNTHES SYNCAGE EVOLUTION SPACER is a medical device that received FDA 510(k) clearance on 2013-05-24. The listed applicant is Synthes (USA) Products, LLC. The 510(k) number is K122639.

When did SYNTHES SYNCAGE EVOLUTION SPACER receive FDA 510(k) clearance?

SYNTHES SYNCAGE EVOLUTION SPACER received FDA 510(k) clearance on 2013-05-24, under 510(k) number K122639.

Who is the listed applicant for SYNTHES SYNCAGE EVOLUTION SPACER?

The FDA 510(k) record lists Synthes (USA) Products, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNTHES SYNCAGE EVOLUTION SPACER?

The FDA product code for SYNTHES SYNCAGE EVOLUTION SPACER is MAX.

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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.