FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
K Number: K083490
·
Decision Mar 18, 2009
Classifications
1
FEI Numbers
275
Registration Numbers
275
Same Product Code
200
Applicant Total
40
Review Days
113
Basic Information
- Device Name
- BIOPRO K-WIRE, MODELS 16863, 17231, 17232, 18577, 18682-18685
- K Number
- K083490
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3040
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BIOPRO, INC.
- Date Received
- November 25, 2008
- Decision Date
- March 18, 2009
- 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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