Triathlon AS-1
FDA 510(k) clearance K203421 · decided 2021-04-19
Clearance details
- K-number
- K203421
- Device name
- Triathlon AS-1
- Applicant
- Conformis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-11-20
- Decision date
- 2021-04-19
- Days to decision
- 150 days
- Clearance type
- Traditional
- Product code
- OOG
- Device class
- 2
- Regulation number
- 888.3560
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Billerica, MA, 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 |
|---|---|---|
| United Orthopedic Knee Patient Specific Instrumentation (K230850) | Enhatch, Inc. | 2023-12-20 |
Recalls involving this device
No recalls on record reference this clearance.