VBB SYSTEM
FDA 510(k) clearance K110604 · decided 2011-12-13
Clearance details
- K-number
- K110604
- Device name
- VBB SYSTEM
- Applicant
- Synthes
- Decision
- Substantially Equivalent
- Date received
- 2011-03-03
- Decision date
- 2011-12-13
- Days to decision
- 285 days
- Clearance type
- Traditional
- Product code
- NDN
- Device class
- 2
- Regulation number
- 888.3027
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- West Chester, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Synthes Inflation System (03.804.4135) Product Usage: Inflation system is used during kyph recall (Z-0877-2015) | PEROUSE MEDICAL | 2014-12-29 |