510(k) K926156
K926156 is an FDA 510(k) premarket notification submitted by Osteo Technology, Inc. for the device "REPLICA(TM) TOTAL HIP SYSTEM". The FDA issued a decision of SN on March 9, 1994. 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. Osteo Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- March 9, 1994
- Date Received
- December 7, 1992
- 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