Double Internal Joint Stabilizer- Elbow— 510(k) K231447
Substantially EquivalentSkeletal Dynamics, Inc.
FDA 510(k) clearance K231447 for Double Internal Joint Stabilizer- Elbow, Substantially Equivalent on 2023-12-15. Applicant: Skeletal Dynamics, Inc.. Device class: 2.
Clearance details
- Applicant
- Skeletal Dynamics, Inc.
- Product code
- Code OZI
- Device class
- Class 2
- Regulation
- 21 CFR 888.3030
- Advisory panel
- Orthopedic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Miami, FL, US
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