NORIAN DRILLABLE
FDA 510(k) clearance K073303 · decided 2008-07-02
Clearance details
- K-number
- K073303
- Device name
- NORIAN DRILLABLE
- Applicant
- Synthes (Usa)
- Decision
- Unknown
- Date received
- 2007-11-23
- Decision date
- 2008-07-02
- Days to decision
- 222 days
- Clearance type
- Traditional
- Product code
- OIS
- 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 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 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| NORIAN SRS BONE CEMENT (P970010/S004) | Synthes (Usa) | 2000-08-31 |
| NORIAN SRS CEMENT (P970010/S002) | Synthes (Usa) | 2000-04-28 |
| NORIAN SRS CEMENT (P970010/S001) | Synthes (Usa) | 1999-07-16 |
| NORIAN SKELETAL REPAIR SYSTEM (SRS) CANCELLOUS BONE CEMENT (P970010) | Synthes (Usa) | 1998-12-23 |