FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
P.F.C. BIPOLAR HIP SYSTEM
K Number: K931655
·
Decision Jun 9, 1994
Classifications
1
FEI Numbers
216
Registration Numbers
216
Same Product Code
96
Applicant Total
22
Review Days
430
Basic Information
- Device Name
- P.F.C. BIPOLAR HIP SYSTEM
- K Number
- K931655
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3390
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- JOHNSON & JOHNSON ORTHOPAEDICS, INC.
- Date Received
- April 5, 1993
- Decision Date
- June 9, 1994
- Product Code
- KWY
- 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 |
|---|---|---|---|
| KWY | Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | 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 |
| 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 |
| K924340 | P.F.C. MOD TOTAL KNEE/CONDYL 3 FEM COMP TIB INSERT | Jan 25, 1994 | Substantially Equivalent |
| K931054 | TRICK MODULAR KNEE TIBIAL TRAY-POROUS | Jan 25, 1994 | Substantially Equivalent |