The following data is part of a premarket notification filed by Medynus Inc. with the FDA for Medynus Iva (acif, Dlif, Plif, Tlif, Alif) Peek Cage.
| Device ID | K212792 |
| 510k Number | K212792 |
| Device Name: | Medynus IVA (ACIF, DLIF, PLIF, TLIF, ALIF) PEEK Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Medynus Inc. 18 Technology Dr. Ste 109 Irvine, CA 92618 |
| Contact | David Shin |
| Correspondent | Jeena Mathai Eerkie Corporation 4027 Runnymeade Dr Collegeville, PA 19426 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-01 |
| Decision Date | 2021-09-23 |