Battalion Universal Spacer System— 510(k) K160958

Name: FDA 510(k) clearance K160958
Creator: U.S. Food and Drug Administration
Published: 2016-09-08

Substantially Equivalent

Alphatec Spine

FDA 510(k) clearance K160958 for Battalion Universal Spacer System, Substantially Equivalent on 2016-09-08. Applicant: Alphatec Spine. Device class: 2.

Clearance details

Applicant: Alphatec Spine
Product code: Code PHM
Device class: Class 2
Regulation: 21 CFR 888.3080
Advisory panel: Orthopedic
Date received: 2016-04-05
Decision date: 2016-09-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsnad, CA, US

Download summary PDF View on FDA.gov ↗

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