NEWPORT SPINAL SYSTEM
FDA 510(k) clearance K083089 · decided 2009-01-13
Clearance details
- K-number
- K083089
- Device name
- NEWPORT SPINAL SYSTEM
- Applicant
- Seaspine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-10-16
- Decision date
- 2009-01-13
- Days to decision
- 89 days
- Clearance type
- Traditional
- Product code
- NKB
- Device class
- 2
- Regulation number
- 888.3070
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra NewPort MIS System Model No. NWPIMP (NewPort Implant Tray w/ Components) NWP2INSTP recall (Z-2182-2014) | Integra LifeSciences Corp. | 2014-08-11 |
| MIS Rod 2, a component of the NewPort System. Model No: 60-0545 (45mm); 60-0550 (50mm); 60 recall (Z-1961-2014) | Integra LifeSciences Corp. | 2014-07-01 |