FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
K Number: K100776
·
Decision Aug 3, 2010
Classifications
1
FEI Numbers
505
Registration Numbers
505
Same Product Code
1254
Applicant Total
402
Review Days
138
Basic Information
- Device Name
- SYNTHES 2.4 MM/2.7 MM VARIABLE ANGLE LCP FOREFOOT/MIDFOOT SYSTEM
- K Number
- K100776
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SYNTHES (USA)
- Date Received
- March 18, 2010
- Decision Date
- August 3, 2010
- Product Code
- HRS
- 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 |
|---|---|---|---|
| HRS | Plate, Fixation, Bone | FDA class 2 | Orthopedic |
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