510(k) K160464 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Opticage(R) Expandable Interbody Fusion Device
| Applicant | Interventional Spine, Inc., Irvine CA, US |
| Decision | Substantially Equivalent, Apr 4, 2016 |
| Received | Feb 19, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K160464
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 27, 2019 | DePuy Spine, Inc. Concorde Lift, Lordotic Expandable Interbody Device, spinal fusion implant 9x23 (197809023L), 9x27 (197809027L), 11 x 23 (197811023L), 11x27 (197811027L), 9x23 (US197809023L), 9x27 (US197809027L) Terminated |
MAX | None listed |
| Jan 3, 2017 | Interventional Spine Inc G3 Opticage Expandable Interbody Fusion Device, Model No. 9180-00, 9180-01, 9180-06, 9180-07, 9180-17, 9101-00, 9101-06
The Opticage Expandable Interbody Fusion Device is a posterior lumbar interverte Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.