FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
KNEE SYSTEM, QUADRAXIAL CONSTRAINED
K Number: K781971
·
Decision Apr 4, 1979
Classifications
1
FEI Numbers
137
Registration Numbers
137
Same Product Code
85
Applicant Total
13
Review Days
128
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Basic Information
- Device Name
- KNEE SYSTEM, QUADRAXIAL CONSTRAINED
- K Number
- K781971
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3510
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Hexcel Medical
- Date Received
- November 27, 1978
- Decision Date
- April 4, 1979
- Product Code
- KRO
- 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 |
|---|---|---|---|
| KRO | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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EVOLUTION® Hinge Knee System;GUARDIAN limb Salvage System;DCW Modular Distal Femoral System;REPIPHYSIS Limb Salvage System;EVOLUTION® MP Total Knee System; EVOLUTION® MP Total Knee System; EVOLUTION® MP Adaptive CS Insert; EVOLUTION® MP Adaptive PS Tibial Insert; EVOLUTION® MP CS/CR Porous Femur/EVOLUTION® Adaptive CS and PS Inserts; EVOLUTION® Revision CCK System; ADVANCE® Double High Insert; ADVANCE® A-CLASS® Tibial Insert; ADVANCE® Knee System; ADVANCE® Ultra-Congruent Tibial Inse
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Other Clearances by Hexcel Medical
| K Number | Device Name | ||
|---|---|---|---|
| K840416 | HEXCELITE | Mar 23, 1984 | Substantially Equivalent |
| K820890 | URETHANE ORTHOPAEDIC CASTING TAPE | Jun 23, 1982 | Substantially Equivalent |
| K812669 | SEATTLE II TOTAL HIP SYSTEM | Oct 2, 1981 | Substantially Equivalent |
| K812687 | BRIGHAM II TOTAL HIP SYSTEM | Oct 2, 1981 | Substantially Equivalent |
| K812068 | PROPOSED CONTROLS FOR DOSIMETRIC RELEASE | Sep 8, 1981 | Substantially Equivalent |
| K811164 | URETHANE ORTHOPAEDIC CASTING TAPE | May 27, 1981 | Substantially Equivalent |
| K810956 | MARCOVE HUMERAL ROD | Apr 17, 1981 | Substantially Equivalent |
| K810957 | MARCOVE INTRAMEDULLARY ROD | Apr 17, 1981 | Substantially Equivalent |
| K810230 | CONDYLAR KNEE W/METAL ENCAPSULATED TIB | Mar 6, 1981 | Substantially Equivalent |
| K800051 | HEXCEL FEMORAL COMPONENT HIP PROSTHESIS | Jan 28, 1980 | Substantially Equivalent |