510(k) K170503 ยท MAX Intervertebral Fusion Device With Bone Graft, Lumbar
EIT Cellular Titanium Cervical Cage, EIT Cellular Titanium PLIF Cages, EIT Cellular Titanium TLIF Cages, and EIT Cellular Titanium ALIF Cages
| Applicant | Eit Emerging Implant Technologies GmbH, Wurmlingen, DE |
| Decision | Substantially Equivalent, Jul 11, 2017 |
| Received | Feb 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K170503
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 20, 2022 | DePuy Spine, Inc. EIT CIF cage, H 6mm, 8degree, L- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD).
Part Number: CUI Open, Classified |
MAX | None listed |
| May 20, 2022 | DePuy Spine, Inc. EIT CIF cage, H 7mm, 8degree, S- an intervertebral body fusion devices indicated for use with autograft when used as an adjunct to fusion in patients with cervical disc disease (DDD)
Part Number: CUI Open, Classified |
MAX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.