ATEC Universal Spacer System— 510(k) K180480

Substantially Equivalent

Alphatec Spine, Inc.

FDA 510(k) clearance K180480 for ATEC Universal Spacer System, Substantially Equivalent on 2018-05-31. Applicant: Alphatec Spine, Inc..

Clearance details

Applicant: Alphatec Spine, Inc.
Product code: Code PHM
Advisory panel: Orthopedic
Date received: 2018-02-23
Decision date: 2018-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsnad, CA, US

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