UNIVERSAL WRIST
FDA 510(k) clearance K940297 · decided 1995-02-06
Clearance details
- K-number
- K940297
- Device name
- UNIVERSAL WRIST
- Applicant
- Turnkey Intergration USA, Inc.
- Decision
- Substantially Equivalent for Some Indications
- Date received
- 1994-01-21
- Decision date
- 1995-02-06
- Days to decision
- 381 days
- Clearance type
- Traditional
- Product code
- JWI
- Device class
- 2
- Regulation number
- 888.3800
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Indianapolis, IN, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Turnkey Intergration USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND (K931265) | Ferguson Medical | 1995-05-22 |
| ASPERGILLUS SP., ANTIGEN (K792687) | Meridian Diagnostics, Inc. | 1980-01-17 |
Recalls involving this device
No recalls on record reference this clearance.