510(k) K071059
K071059 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DEPUY SPA POROUS COATED PROXIMAL SLEEVE". The FDA issued a decision of Substantially Equivalent on November 9, 2007. The device falls under product code KWZ (Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer), a Class II device regulated under 21 CFR 888.3310. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 2007
- Date Received
- April 16, 2007
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Constrained, Cemented Or Uncemented, Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3310
- Review Panel
- OR
- Submission Type