NFIX II PEDICLE SCREW SYSTEM
FDA 510(k) clearance K061774 · decided 2006-12-13
Clearance details
- K-number
- K061774
- Device name
- NFIX II PEDICLE SCREW SYSTEM
- Applicant
- N Spine, Inc.
- Decision
- Unknown
- Date received
- 2006-06-23
- Decision date
- 2006-12-13
- Days to decision
- 173 days
- Clearance type
- Traditional
- Product code
- NQP
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TI N-Hance Rod 150mm Sterile The Synthes N-Hance and NFix II rods are intended to provide recall (Z-2344-2010) | Synthes USA (HQ), Inc. | 2010-09-01 |
| N-Hance System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobili recall (Z-2345-2010) | Synthes USA (HQ), Inc. | 2010-09-01 |
| NFix II System 150mm The Synthes N-Hance and NFix II rods are intended to provide immobili recall (Z-2346-2010) | Synthes USA (HQ), Inc. | 2010-09-01 |
| NFlex Straight monosegmental L 150mm The Synthes N-Hance and NFix II rods are intended to recall (Z-2347-2010) | Synthes USA (HQ), Inc. | 2010-09-01 |
| NFlex Stabilization System 150mm The Synthes N-Hance and NFix II rods are intended to prov recall (Z-2348-2010) | Synthes USA (HQ), Inc. | 2010-09-01 |
| NFix II System 150 mm, Catalog number NX60150-1 spinal fusion surgery recall (Z-0963-2009) | Synthes Spine | 2009-02-03 |
| NFix II System 200 mm, Catalog number NX60200-1. spinal fusion surgery recall (Z-0964-2009) | Synthes Spine | 2009-02-03 |