Craniomaxillofacial Distraction System (CMFD)— 510(k) K170818

Substantially Equivalent

Synthes USA Products, LLC

FDA 510(k) clearance K170818 for Craniomaxillofacial Distraction System (CMFD), Substantially Equivalent on 2017-12-07. Applicant: Synthes USA Products, LLC.

Clearance details

Applicant: Synthes USA Products, LLC
Product code: Code PBJ
Advisory panel: Neurology
Date received: 2017-03-20
Decision date: 2017-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Chester, PA, US

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