510(k) K990523
K990523 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "B2C, ESPACE REVISION CUP SYSTEM". The FDA issued a decision of Substantially Equivalent on April 30, 1999. The device falls under product code LPH (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented), a Class II device regulated under 21 CFR 888.3358. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 30, 1999
- Date Received
- February 19, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3358
- Review Panel
- OR
- Submission Type