NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
FDA 510(k) clearance K102722 · decided 2011-01-27
Clearance details
- K-number
- K102722
- Device name
- NORIAN DRILLABLE INJECT, NORIAN DRILLABLE FAST SET PUTTY
- Applicant
- Synthes USA Products, LLC
- Decision
- Substantially Equivalent
- Date received
- 2010-09-21
- Decision date
- 2011-01-27
- Days to decision
- 128 days
- Clearance type
- Traditional
- Product code
- MQV
- Device class
- 2
- Regulation number
- 888.3045
- 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 |
|---|---|---|
| Norian Drillable Inject 3 CC-Sterile; catalog # 07.704.003S Intended for bony voids or def recall (Z-1942-2016) | Synthes (USA) Products LLC | 2016-06-09 |
| Norian Drillable Inject 5 CC-Sterile; catalog # 07.704.005S Intended for bony voids or def recall (Z-1943-2016) | Synthes (USA) Products LLC | 2016-06-09 |
| Norian Drillable Inject 10 CC-Sterile; catalog # 07.704.010S Intended for bony voids or de recall (Z-1944-2016) | Synthes (USA) Products LLC | 2016-06-09 |