primaLOK SP Interspinous Fusion System— 510(k) K231807

Name: FDA 510(k) clearance K231807
Creator: U.S. Food and Drug Administration
Published: 2023-08-15

Substantially Equivalent

Wenzel Spine, Inc.

FDA 510(k) clearance K231807 for primaLOK SP Interspinous Fusion System, Substantially Equivalent on 2023-08-15. Applicant: Wenzel Spine, Inc.. Device class: 2.

Clearance details

Applicant: Wenzel Spine, Inc.
Product code: Code PEK
Device class: Class 2
Regulation: 21 CFR 888.3050
Advisory panel: Orthopedic
Date received: 2023-06-20
Decision date: 2023-08-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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