510(k) K965198
K965198 is an FDA 510(k) premarket notification submitted by Johnson & Johnson International for the device "ULTIMA TPS CEMENTED STEM". The FDA issued a decision of Substantially Equivalent on July 23, 1997. The device falls under product code KWL (Prosthesis, Hip, Hemi-, Femoral, Metal), a Class II device regulated under 21 CFR 888.3360. Johnson & Johnson International has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 23, 1997
- Date Received
- December 26, 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