510(k) K923911
K923911 is an FDA 510(k) premarket notification submitted by Turnkey Intergration USA, Inc. for the device "INTRINSIC STEM". The FDA issued a decision of Substantially Equivalent on April 14, 1993. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. Turnkey Intergration USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1993
- Date Received
- August 4, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type