SYGNAL DBM— 510(k) K080405

Name: FDA 510(k) clearance K080405
Creator: U.S. Food and Drug Administration
Published: 2008-08-28

Substantially Equivalent

Musculoskeletal Transplant Foundation

FDA 510(k) clearance K080405 for SYGNAL DBM, Substantially Equivalent on 2008-08-28. Applicant: Musculoskeletal Transplant Foundation. Device class: 2.

Clearance details

Applicant: Musculoskeletal Transplant Foundation
Product code: Code MBP
Device class: Class 2
Regulation: 21 CFR 888.3045
Advisory panel: Orthopedic
Date received: 2008-02-14
Decision date: 2008-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Edison, NJ, US

Download summary PDF View on FDA.gov ↗

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