FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇭 Switzerland
VIPER PRIME additions to the VIPER® System
K Number: K162912
·
Decision Dec 8, 2016
Classifications
1
FEI Numbers
413
Registration Numbers
413
Same Product Code
873
Applicant Total
2
Review Days
52
Basic Information
- Device Name
- VIPER PRIME additions to the VIPER® System
- K Number
- K162912
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 888.3070
- Medical Specialty
- Orthopedic
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- MEDOS INTERNATIONAL, SARL
- Date Received
- October 17, 2016
- Decision Date
- December 8, 2016
- Product Code
- NKB
- 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 |
|---|---|---|---|
| NKB | Thoracolumbosacral Pedicle Screw System | FDA class 2 | Orthopedic |
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Other Clearances by MEDOS INTERNATIONAL, SARL
| K Number | Device Name | ||
|---|---|---|---|
| K140759 | BENGAL SYSTEM, BENGAL STACKABLE SYSTEM, CONCORDE BULLET LUMBAR, CONCORDE INLINE LUMBAR, COUGAR SYSTEM, COUGAR LS LATERAL | Jun 13, 2014 | Substantially Equivalent |