510(k) K962646
K962646 is an FDA 510(k) premarket notification submitted by Orthopaedic Innovations, Inc. for the device "PRIME MODULAR ENDO HEAD". The FDA issued a decision of Substantially Equivalent on September 23, 1996. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Orthopaedic Innovations, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1996
- Date Received
- July 8, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Hip, Hemi-, Femoral, Metal
- Device Class
- Class II
- Regulation Number
- 888.3360
- Review Panel
- OR
- Submission Type