FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
K4 BONE SCREW SYSTEM
K Number: K950704
·
Decision Jun 30, 1995
Classifications
1
FEI Numbers
659
Registration Numbers
659
Same Product Code
1058
Applicant Total
19
Review Days
135
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Basic Information
- Device Name
- K4 BONE SCREW SYSTEM
- K Number
- K950704
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Kinetikos Medical, Inc.
- Date Received
- February 15, 1995
- Decision Date
- June 30, 1995
- Product Code
- HWC
- 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 |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | FDA class 2 | Orthopedic |
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| K040356 | KOMPRESSOR SCREW SYSTEM | Mar 1, 2004 | Substantially Equivalent |
| K024233 | KOMPRESSOR SCREW SYSTEM | Feb 6, 2003 | Substantially Equivalent |
| K030037 | UNIVERSAL TOTAL WRIST SYSTEM | Feb 5, 2003 | Substantially Equivalent |
| K023770 | K2 HEMI TOE IMPLANT SYSTEM (FORMERLY ZOBEL GREAT TOE IMPLANT SYSTEM) | Dec 12, 2002 | Substantially Equivalent |
| K020554 | MODIFICATION TO UNIVERSAL TOTAL WRIST SYSTEM | May 3, 2002 | Substantially Equivalent |