FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
K Number: K043113
·
Decision Jan 21, 2005
Classifications
1
FEI Numbers
247
Registration Numbers
247
Same Product Code
392
Applicant Total
194
Review Days
72
Basic Information
- Device Name
- TEMPFIX EXTERNAL FIXATION SYSTEM, MR SAFE
- K Number
- K043113
- Device Class
- FDA class 2
- Clearance Type
- Abbreviated
- Regulation Number
- 888.3030
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- DEPUY ORTHOPAEDICS, INC.
- Date Received
- November 10, 2004
- Decision Date
- January 21, 2005
- Product Code
- KTT
- 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 |
|---|---|---|---|
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | FDA class 2 | Orthopedic |
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