S-LIF INTERVERTEBRAL BODY FUSION DEVICE
FDA 510(k) clearance K092815 · decided 2010-06-30
Clearance details
- K-number
- K092815
- Device name
- S-LIF INTERVERTEBRAL BODY FUSION DEVICE
- Applicant
- Spinefrontier, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-09-14
- Decision date
- 2010-06-30
- Days to decision
- 289 days
- Clearance type
- Abbreviated
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Beverly, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| SpineFrontier S-Lift Lock Shaft Inserter, an instrument used with S-LIFT Intervertebral Bo recall (Z-1565-2014) | SpineFrontier, Inc. | 2014-05-07 |
| S-LIFT Extension Shims Extension shims are manufactured from grade 5 titanium and are curv recall (Z-0274-2014) | SpineFrontier, Inc. | 2013-11-14 |
| T-Handle, Strike Plate, Push Connection, Part Number: SI50023 Rev A T-handles are silicone recall (Z-1932-2013) | SpineFrontier, Inc. | 2013-08-08 |
| BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure a recall (Z-1664-2013) | SpineFrontier, Inc. | 2013-07-05 |
| S-LIFT Inserter Outer Sleeve Product Usage: The Inserter Sleeve is an optional instrument recall (Z-1665-2013) | SpineFrontier, Inc. | 2013-07-05 |
| S-Lift Implant Guides (also known as S-LIF) Compressor Part Number: 11-50223 Product Usage recall (Z-0417-2013) | SpineFrontier, Inc. | 2012-11-21 |