FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
MODIFICATION TO SMARTPIN
K Number: K041288
·
Decision Jun 10, 2004
Classifications
1
FEI Numbers
283
Registration Numbers
283
Same Product Code
203
Applicant Total
3
Review Days
28
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Basic Information
- Device Name
- MODIFICATION TO SMARTPIN
- K Number
- K041288
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Linvatec Biomaterials, Inc.
- Date Received
- May 13, 2004
- Decision Date
- June 10, 2004
- 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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