FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL
K Number: K910563
·
Decision May 23, 1991
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
22
Review Days
104
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Basic Information
- Device Name
- P.F.C.(R) MODULAR KNEE SYST, STAB ALL-PLAST TIBIAL
- K Number
- K910563
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Johnson & Johnson Orthopaedics, Inc.
- Date Received
- February 8, 1991
- Decision Date
- May 23, 1991
- Product Code
- JWH
- Advisory Committee
- Orthopedic
- Review Advisory Committee
- OR
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JWH | Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | FDA class 2 | Orthopedic |
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Other Clearances by Johnson & Johnson Orthopaedics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K931466 | PFC MODULAR TOTAL KNEE SYSTEM, POROUS COATED SACRI | Dec 6, 1994 | Substantially Equivalent |
| K935452 | P.F.C. 2 TOTAL HIP SYSTEM POROUS COATED MODULAR FEMORAL COMPONENT | Oct 6, 1994 | Substantially Equivalent |
| K940190 | ULTIMA UNIPOLAR MODULAR HEAD | Sep 29, 1994 | Substantially Equivalent |
| K933275 | P.F.C. CERAMIC HIP HEAD | Sep 28, 1994 | Substantially Equivalent |
| K932595 | ORTHOSORB(TM) ABSORBABLE CEMENT RESTRICTOR | Sep 20, 1994 | Substantially Equivalent |
| K931655 | P.F.C. BIPOLAR HIP SYSTEM | Jun 9, 1994 | Substantially Equivalent |
| K933867 | UNIVERSAL INSET PATELLA | Jun 6, 1994 | Substantially Equivalent for Some Indications |
| K935262 | P.F.C. TOTAL KNEE SYSTEM OVAL PATELLA | Jun 3, 1994 | Substantially Equivalent for Some Indications |
| K931189 | P.F.C. TOTAL HIP SYSTEM POROUS COATED MODULAR ACET | Feb 9, 1994 | Substantially Equivalent |
| K931054 | TRICK MODULAR KNEE TIBIAL TRAY-POROUS | Jan 25, 1994 | Substantially Equivalent |