510(k) K172009 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Cascadia Interbody System
| Applicant | K2m, Inc., Leesburg VA, US |
| Decision | Substantially Equivalent, Dec 14, 2017 |
| Received | Jul 3, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172009
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 7, 2021 | K2M, Inc Cascadia AN Interbody Convex 10x22x14mm
Catalog Number: 6101-2102214NC-G2
Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft comprised Terminated |
MAX | None listed |
| May 7, 2021 | K2M, Inc Cascadia AN Interbody Convex 10x22x15mm
Catalog Number: 6101-2102215NC-G2
Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft compris Terminated |
MAX | None listed |
| May 7, 2021 | K2M, Inc Cascadia AN Interbody Convex 10x28x14mm
Catalog Number: 6101-2102814NC-G2
Lumbar implants are intervertebral body fusion devices indicated for use with autograft and/or allogenic bone graft compris Terminated |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.