510(k) K050848
K050848 is an FDA 510(k) premarket notification submitted by Tornier for the device "TORNIER ELBOW PROSTHESIS". The FDA issued a decision of Substantially Equivalent on Jul 14, 2005. The device falls under product code JDB (Prosthesis, Elbow, Semi-Constrained, Cemented), a Class II device regulated under 21 CFR 888.3160. Tornier has 115 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jul 14, 2005
- Date Received
- Apr 4, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Elbow, Semi-Constrained, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3160
- Review Panel
- OR
- Submission Type
- 510(k)