FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
K Number: K050041
·
Decision Feb 25, 2005
Classifications
1
FEI Numbers
153
Registration Numbers
153
Same Product Code
127
Applicant Total
402
Review Days
49
Basic Information
- Device Name
- SYNTHES (USA) STERILE STERNAL FIXATION SYSTEM
- K Number
- K050041
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3010
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- SYNTHES (USA)
- Date Received
- January 7, 2005
- Decision Date
- February 25, 2005
- Product Code
- JDQ
- 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 |
|---|---|---|---|
| JDQ | Cerclage, Fixation | FDA class 2 | Orthopedic |
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