510(k) K923807
K923807 is an FDA 510(k) premarket notification submitted by Johnson & Johnson International for the device "P.F.C. MODULAR TOTAL KNEE SYSTEM, MODULAR PLUS". The FDA issued a decision of Substantially Equivalent on November 9, 1992. The device falls under product code JWH (Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer), a Class II device regulated under 21 CFR 888.3560. Johnson & Johnson International has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 9, 1992
- Date Received
- July 29, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Device Class
- Class II
- Regulation Number
- 888.3560
- Review Panel
- OR
- Submission Type