United Orthopedic Knee Patient Specific Instrumentation
FDA 510(k) clearance K230850 · decided 2023-12-20
Clearance details
- K-number
- K230850
- Device name
- United Orthopedic Knee Patient Specific Instrumentation
- Applicant
- Enhatch, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2023-03-28
- Decision date
- 2023-12-20
- Days to decision
- 267 days
- Clearance type
- Traditional
- Product code
- OOG
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Hasbrouck Heights, NJ, 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 |
|---|---|---|
| Triathlon AS-1 (K203421) | Conformis, Inc. | 2021-04-19 |
Recalls involving this device
No recalls on record reference this clearance.