510(k) K972435
K972435 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "ULTIMA AND ULTIMA LX CEMENTED FEMORAL STEM". The FDA issued a decision of Substantially Equivalent on September 11, 1997. The device falls under product code JDI (Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented), a Class II device regulated under 21 CFR 888.3350. Johnson & Johnson Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 11, 1997
- Date Received
- June 30, 1997
- 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