TRANSFX EXTERNAL FIXATION SYSTEM— 510(k) K984357
Substantially EquivalentImmedica, Inc.
FDA 510(k) clearance K984357 for TRANSFX EXTERNAL FIXATION SYSTEM, Substantially Equivalent on 1999-03-04. Applicant: Immedica, Inc.. Device class: 2.
Clearance details
- Applicant
- Immedica, Inc.
- 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
- Traditional
- Location
- Chatham, NJ, US
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