Internal Joint Stabilizer - Elbow
FDA 510(k) clearance K223318 · decided 2023-05-10
Clearance details
- K-number
- K223318
- Device name
- Internal Joint Stabilizer - Elbow
- Applicant
- Skeletal Dynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-10-28
- Decision date
- 2023-05-10
- Days to decision
- 194 days
- Clearance type
- Traditional
- Product code
- OZI
- Device class
- 2
- Regulation number
- 888.3030
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Double Internal Joint Stabilizer- Elbow (K231447) | Skeletal Dynamics, Inc. | 2023-12-15 |
| Internal Joint Stabilizer - Elbow (K153208) | Skeletal Dynamics, LLC | 2015-12-31 |
Recalls involving this device
No recalls on record reference this clearance.