Opticage Expandable Interbody Fusion Device
FDA 510(k) clearance K152156 · decided 2015-10-19
Clearance details
- K-number
- K152156
- Device name
- Opticage Expandable Interbody Fusion Device
- Applicant
- Interventional Spine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2015-08-03
- Decision date
- 2015-10-19
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- MAX
- Device class
- 2
- Regulation number
- 888.3080
- Medical specialty
- Orthopedic
- Advisory committee
- Orthopedic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023 recall (Z-1226-2019) | DePuy Spine, Inc. | 2019-04-27 |
| G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180- recall (Z-0941-2017) | Interventional Spine Inc | 2017-01-03 |