AXLE INTERSPINOUS FUSION SYSTEM— 510(k) K130438

Substantially Equivalent

X-Spine Systems, Inc.

FDA 510(k) clearance K130438 for AXLE INTERSPINOUS FUSION SYSTEM, Substantially Equivalent on 2013-06-27. Applicant: X-Spine Systems, Inc..

Clearance details

Applicant: X-Spine Systems, Inc.
Product code: Code PEK
Advisory panel: Orthopedic
Date received: 2013-02-21
Decision date: 2013-06-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Miamisburg, OH, US

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