HOFFMAN II HYBRID RING CLAMP— 510(k) K011948

Name: FDA 510(k) clearance K011948
Creator: U.S. Food and Drug Administration
Published: 2001-07-13

Substantially Equivalent

Howmedica Osteonics Corp.

FDA 510(k) clearance K011948 for HOFFMAN II HYBRID RING CLAMP, Substantially Equivalent on 2001-07-13. Applicant: Howmedica Osteonics Corp.. Device class: 2.

Clearance details

Applicant: Howmedica Osteonics Corp.
Product code: Code LXT
Device class: Class 2
Regulation: 21 CFR 888.3030
Advisory panel: Orthopedic
Date received: 2001-06-21
Decision date: 2001-07-13
Decision: Substantially Equivalent
Clearance type: Special
Location: Allendale, NJ, US

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