FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ORION BLADE PLATE FOR TIBIAL OSTEOTOMY
K Number: K901272
·
Decision Apr 23, 1990
Classifications
1
FEI Numbers
249
Registration Numbers
249
Same Product Code
403
Applicant Total
16
Review Days
35
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Basic Information
- Device Name
- ORION BLADE PLATE FOR TIBIAL OSTEOTOMY
- K Number
- K901272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Applicant
- Med-Tek Corp.
- Date Received
- March 19, 1990
- Decision Date
- April 23, 1990
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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Other Clearances by Med-Tek Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K903234 | F-19 TOTAL HIP PROSTHESIS | Oct 10, 1990 | Substantially Equivalent |
| K901687 | F-24 FEMORAL HIP PROSTHESIS | Sep 7, 1990 | Substantially Equivalent |
| K901451 | F-20 CEMENTED METAL-BACKED ACETABULAR CUP | Aug 31, 1990 | Substantially Equivalent for Some Indications |
| K900428 | ANESTHESIA BREATHING CIRCUITS | Aug 17, 1990 | Substantially Equivalent |
| K901626 | H.N. METAL BACKED ACETABULAR CUP, NONCEMENTED | Aug 14, 1990 | Substantially Equivalent |
| K901594 | H.N. TOTAL HIP PROSTHESIS | Aug 3, 1990 | Substantially Equivalent |
| K901480 | F-20 TOTAL HIP PROSTHESIS | Jun 12, 1990 | Substantially Equivalent |
| K901273 | L.M.S. SELF-DETACHABLE BROACH WITH STOP | Jun 5, 1990 | Substantially Equivalent |
| K901240 | ASTEL NON-METAL BACKED ACETABULAR CUP FOR CEMENTED | Mar 26, 1990 | Substantially Equivalent |
| K894978 | BACTERIAL FILTER | Nov 2, 1989 | Substantially Equivalent |