FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES
K Number: K970257
·
Decision May 22, 1997
Classifications
1
FEI Numbers
302
Registration Numbers
302
Same Product Code
528
Applicant Total
57
Review Days
119
Basic Information
- Device Name
- FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES
- K Number
- K970257
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3020
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ferguson Medical
- Date Received
- January 23, 1997
- Decision Date
- May 22, 1997
- 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 Ferguson Medical
| K Number | Device Name | ||
|---|---|---|---|
| K033153 | DICOM THEATER | Apr 23, 2004 | Substantially Equivalent |
| K963794 | PUNCTURENEEDLE | Mar 19, 1998 | Substantially Equivalent |
| K962615 | TUMORLOCALIZER MRI | Mar 19, 1998 | Substantially Equivalent |
| K971813 | EMBLA | Jan 16, 1998 | Substantially Equivalent |
| K972217 | ORTHOPEDIC SCREW SYSTEM | Nov 20, 1997 | Substantially Equivalent |
| K972219 | ORTHOPEDIC PLATE SYSTEM | Nov 20, 1997 | Substantially Equivalent |
| K970819 | TARGOBEAM | Jul 14, 1997 | Substantially Equivalent |
| K970280 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES | May 22, 1997 | Substantially Equivalent |
| K970258 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES | May 22, 1997 | Substantially Equivalent |
| K960421 | SINUSCAN 102/SINUSPRINT | Apr 16, 1997 | Substantially Equivalent |