510(k) K940297
K940297 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "UNIVERSAL WRIST". The FDA issued a decision of SN on February 6, 1995. The device falls under product code JWI (Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- February 6, 1995
- Date Received
- January 21, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained
- Device Class
- Class II
- Regulation Number
- 888.3800
- Review Panel
- OR
- Submission Type