Spinal Elements' Spinous Process Plate System— 510(k) K160465

Substantially Equivalent

Spinal Elements, Inc.

FDA 510(k) clearance K160465 for Spinal Elements' Spinous Process Plate System, Substantially Equivalent on 2016-07-28. Applicant: Spinal Elements, Inc..

Clearance details

Applicant: Spinal Elements, Inc.
Product code: Code PEK
Advisory panel: Orthopedic
Date received: 2016-02-19
Decision date: 2016-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, US

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