510(k) K971189
K971189 is an FDA 510(k) premarket notification submitted by Johnson & Johnson Professionals, Inc. for the device "P.F.C. SIGMA KNEE SYSTEM (SIZE 1.5)". The FDA issued a decision of Substantially Equivalent on July 17, 1997. 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 Professionals, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 17, 1997
- Date Received
- April 1, 1997
- 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