FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
UNIVERSAL WRIST
K Number: K940297
·
Decision Feb 6, 1995
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
26
Review Days
381
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Basic Information
- Device Name
- UNIVERSAL WRIST
- K Number
- K940297
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Turnkey Intergration USA, Inc.
- Date Received
- January 21, 1994
- Decision Date
- February 6, 1995
- Product Code
- JWI
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWI | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWI), ordered by most recent decision date.
FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND
FDA 510(k)
FDA Class 2
·Orthopedic
ASPERGILLUS SP., ANTIGEN
FDA 510(k)
FDA Class 2
·Orthopedic
Other Clearances by Turnkey Intergration USA, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K991405 | OMNI-FIX, HUMERAL NAIL | Jun 29, 1999 | Substantially Equivalent |
| K990523 | B2C, ESPACE REVISION CUP SYSTEM | Apr 30, 1999 | Substantially Equivalent |
| K990307 | OMNI-FIX, NAIL SYSTEM | Apr 1, 1999 | Substantially Equivalent |
| K972411 | LINK CEMENT PLUG | Aug 29, 1997 | Substantially Equivalent |
| K970284 | ARTOS, DIPLOS SYSTEM | Apr 21, 1997 | Substantially Equivalent |
| K970084 | LINK CERCLAGE WIRE SYSTEM | Mar 13, 1997 | Substantially Equivalent |
| K953653 | LUBINUS SP II HIP SYSTEM | Nov 6, 1995 | Substantially Equivalent |
| K943986 | LINK ENDO MODEL REVISION CUP | Jul 5, 1995 | Substantially Equivalent |
| K951355 | LINK SADDLE PROTHESIS | May 25, 1995 | Substantially Equivalent |
| K950397 | SYSTEM 22 VALVE | Apr 14, 1995 | Substantially Equivalent |