FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONDYLAR KNEE W/METAL ENCAPSULATED TIB
K Number: K810230
·
Decision Mar 6, 1981
Classifications
1
FEI Numbers
124
Registration Numbers
124
Same Product Code
90
Applicant Total
13
Review Days
38
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Basic Information
- Device Name
- CONDYLAR KNEE W/METAL ENCAPSULATED TIB
- K Number
- K810230
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3530
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Hexcel Medical
- Date Received
- January 27, 1981
- Decision Date
- March 6, 1981
- Product Code
- HRY
- 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 |
|---|---|---|---|
| HRY | Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | FDA class 2 | Orthopedic |
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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 |
| K800051 | HEXCEL FEMORAL COMPONENT HIP PROSTHESIS | Jan 28, 1980 | Substantially Equivalent |
| K800050 | ANITOMIC TOTAL HIP SYSTEM | Jan 24, 1980 | Substantially Equivalent |