FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND
K Number: K931265
·
Decision May 22, 1995
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
2
Applicant Total
57
Review Days
805
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- FIXANO TOTAL TRAPEZIO METACARPAL PROSTHESIS, 2ND
- K Number
- K931265
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3800
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- Ferguson Medical
- Date Received
- March 8, 1993
- Decision Date
- May 22, 1995
- Product Code
- JWI
- 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 |
|---|---|---|---|
| JWI | Prosthesis, Wrist, 2 Part Metal-Plastic Articulation, Semi-Constrained | FDA class 2 | Orthopedic |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JWI), ordered by most recent decision date.
UNIVERSAL WRIST
FDA 510(k)
FDA Class 2
·Orthopedic
ASPERGILLUS SP., ANTIGEN
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 |
| 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 |
| K970257 | FIXANO D.S.S. (DOUBLE SLIDING SCREWS) SYSTEM FOR OSTEOSYNTHESIS OF SUB-TROCHANTERIAN FRACTURES | May 22, 1997 | Substantially Equivalent |