FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF PER-TROCHANTEROAM FRACTURES
K Number: K970280
·
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 PER-TROCHANTEROAM FRACTURES
- K Number
- K970280
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (HSB), ordered by most recent decision date.
AND Medical Femoral Nail System (PFNA01); AND Medical Femoral Nail System (PFNA02)
FDA 510(k)
FDA Class 2
·Orthopedic
Precice Max System and Precice Ankle Salvage System
FDA 510(k)
FDA Class 2
·Orthopedic
Fule Metallic Lockable Intramedullary Nail Systems
FDA 510(k)
FDA Class 2
·Orthopedic
HERA Interlocking Intramedullary Nailing System
FDA 510(k)
FDA Class 2
·Orthopedic
FITBONE® TRANSPORT AND LENGTHENING SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
Fitbone Trochanteric, FITBONE® Transport and Lengthening System, FITBONE® TAA
FDA 510(k)
FDA Class 2
·Orthopedic
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 |
| K970258 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHSIS OF UNSTABLE FEMORAL NECK FRACTURES | May 22, 1997 | Substantially Equivalent |
| K970257 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES | May 22, 1997 | Substantially Equivalent |
| K960421 | SINUSCAN 102/SINUSPRINT | Apr 16, 1997 | Substantially Equivalent |