510(k) K231807— primaLOK SP Interspinous Fusion System

Substantially Equivalent

Wenzel Spine, Inc.

Clearance details

Applicant: Wenzel Spine, Inc.
Product code: Code PEK
Advisory panel: Orthopedic
Date received: 2023-06-20
Decision date: 2023-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

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