510(k) K030122
K030122 is an FDA 510(k) premarket notification submitted by DePuy Orthopaedics, Inc. for the device "DEPUY SUMMIT BASIC PRESS-FIT HIP STEM". The FDA issued a decision of Substantially Equivalent on February 5, 2003. The device falls under product code LWJ (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented), a Class II device regulated under 21 CFR 888.3360. DePuy Orthopaedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 2003
- Date Received
- January 14, 2003
- Clearance Type
- Special
- 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