The following data is part of a premarket notification filed by Nvision Biomedical Technologies, Inc. with the FDA for Earp Interbody System.
| Device ID | K212477 |
| 510k Number | K212477 |
| Device Name: | EARP Interbody System |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Nvision Biomedical Technologies, Inc. 4590 Lockhill Selma San Antonio, TX 78249 |
| Contact | Diana Langham |
| Correspondent | Jeffrey Brittan Watershed Idea Foundry 1815 Aston Ave., Suite 106 Carlsbad, CA 92008 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-09 |
| Decision Date | 2022-04-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810135960007 | K212477 | 000 |