510(k) K031474
K031474 is an FDA 510(k) premarket notification submitted by Orthopedic Alliance, LLC for the device "SC TOTAL HIP SYSTEM". The FDA issued a decision of Substantially Equivalent on October 15, 2003. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Orthopedic Alliance, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 2003
- Date Received
- May 9, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented
- Device Class
- Class II
- Regulation Number
- 888.3350
- Review Panel
- OR
- Submission Type