FDA 510(k)
FDA class 2
Substantially Equivalent
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NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220
K Number: K983121
·
Decision Oct 5, 1998
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
13
Review Days
27
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Basic Information
- Device Name
- NON-STERILE KIRSCHNER WIRES AND STEINMANN PINS, MODELS #'S 290-101/160, 290-201/216, 290-060/330, 290-161/220
- K Number
- K983121
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Syntec Scientific Corp.
- Date Received
- September 8, 1998
- Decision Date
- October 5, 1998
- Product Code
- HTY
- 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 |
|---|---|---|---|
| HTY | Pin, Fixation, Smooth | FDA class 2 | Orthopedic |
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