FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT
K Number: K963255
·
Decision Jan 2, 1997
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
910
Applicant Total
10
Review Days
136
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Basic Information
- Device Name
- PROFIX PLUS TIBIAL INSERT, PROFIX PS PLUS TIBIAL INSERT, PROFIX P/S TIBIAL INSERT
- K Number
- K963255
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3560
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Smith & Nephew, Inc., Orthopaedic Div.
- Date Received
- August 19, 1996
- Decision Date
- January 2, 1997
- 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 Smith & Nephew, Inc., Orthopaedic Div.
| K Number | Device Name | ||
|---|---|---|---|
| K991538 | OPERA CUPFLANGED ACETABULAR COMPONENTS | Jun 3, 1999 | Substantially Equivalent |
| K970635 | TITANIUM SPINAL ROD SYSTEM | Aug 14, 1997 | Substantially Equivalent |
| K971414 | ZIRCONIA PROZYR CERAMIC 12/14 GLOBAL TAPER (GT) FEMORAL HEADS | Jul 16, 1997 | Substantially Equivalent |
| K970748 | TAYLOR SPATIAL FRAME EXTERNAL FIXATION SYSTEM | May 9, 1997 | Substantially Equivalent |
| K970751 | HEIDELBERG EXTERNAL FIXATOR | Apr 16, 1997 | Substantially Equivalent |
| K970713 | COMPASS UNIVERSAL HINGE | Apr 3, 1997 | Substantially Equivalent |
| K970351 | GLOBAL TAPER SPECTRON HIP STEMS | Feb 28, 1997 | Substantially Equivalent |
| K970337 | HA GLOBAL TAPER (GT) TAPERED HIP STEM | Feb 28, 1997 | Substantially Equivalent |
| K962784 | ULTIUM SPINAL PLATING SYSTEM | Oct 2, 1996 | Substantially Equivalent for Some Indications |