TRUE/LOK MONOLATERAL/BILATERAL FIXATOR— 510(k) K941048
Substantially EquivalentApplied Osteo Systems, Inc.
FDA 510(k) clearance K941048 for TRUE/LOK MONOLATERAL/BILATERAL FIXATOR, Substantially Equivalent on 1994-10-03. Applicant: Applied Osteo Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Applied Osteo Systems, 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
- Walnut Creek, CA, US
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