FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
K Number: K012967
·
Decision Oct 4, 2001
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
9
Review Days
30
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Basic Information
- Device Name
- MODIFICATION TO FIXION INTERLOCKING PROXIMAL FEMORAL INTRAMEDULLARY NAILING SYSTEM
- K Number
- K012967
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Disco-O-Tech Medical Technologies, Ltd.
- Date Received
- September 4, 2001
- Decision Date
- October 4, 2001
- Product Code
- HSB
- 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 |
|---|---|---|---|
| HSB | Rod, Fixation, Intramedullary And Accessories | FDA class 2 | Orthopedic |
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Other Clearances by Disco-O-Tech Medical Technologies, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K032588 | MODIFICATION TO FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM) | Sep 12, 2003 | Substantially Equivalent |
| K031401 | FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) | Aug 6, 2003 | Substantially Equivalent |
| K023437 | FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL | Nov 14, 2002 | Substantially Equivalent |
| K021324 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAILING SYSTEM) | May 23, 2002 | Substantially Equivalent |
| K003212 | FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) | Dec 28, 2000 | Substantially Equivalent |
| K003215 | MODIFICATION OF FIXION INTRAMEDULLARY NAILING SYSTEM (FIXION IM NAIL) | Dec 27, 2000 | Substantially Equivalent |
| K002783 | FIXION INTERLOCKING NAIL (FIXION IL NAIL) | Dec 5, 2000 | Substantially Equivalent |
| K990717 | FIXION INTRAMEDULLARY NAILING SYSTEM | Jun 2, 1999 | Substantially Equivalent |