FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES (USA) TIBIAL NAIL SYSTEM EX
K Number: K040762
·
Decision Apr 12, 2004
Classifications
1
FEI Numbers
115
Registration Numbers
115
Same Product Code
52
Applicant Total
402
Review Days
18
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Basic Information
- Device Name
- SYNTHES (USA) TIBIAL NAIL SYSTEM EX
- K Number
- K040762
- 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 25, 2004
- Decision Date
- April 12, 2004
- Product Code
- JDS
- 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 |
|---|---|---|---|
| JDS | Nail, Fixation, Bone | FDA class 2 | Orthopedic |
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