MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM— 510(k) K013772
Substantially EquivalentHowmedica Osteonics
FDA 510(k) clearance K013772 for MODIFICATION TO HOFFMANN II MICRO EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 2001-12-03. Applicant: Howmedica Osteonics. Device class: 2.
Clearance details
- Applicant
- Howmedica Osteonics
- Product code
- Code LXT
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Allendale, NJ, US
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