BERLIN EXTERNAL FIXATOR— 510(k) K954053
Substantially EquivalentEncore Orthopedics, Inc.
FDA 510(k) clearance K954053 for BERLIN EXTERNAL FIXATOR, Substantially Equivalent on 1996-05-16. Applicant: Encore Orthopedics, Inc.. Device class: 2.
Clearance details
- Applicant
- Encore Orthopedics, 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
- Austin, TX, US
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