The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Proposed Optimus.
| Device ID | K132596 |
| 510k Number | K132596 |
| Device Name: | PROPOSED OPTIMUS |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | CUSTOM SPINE, INC. 9 Campus Dr Parsippany, NJ 07054 |
| Contact | Hanaa Shahin |
| Correspondent | Hanaa Shahin CUSTOM SPINE, INC. 9 Campus Dr Parsippany, NJ 07054 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-19 |
| Decision Date | 2014-04-11 |
| Summary: | summary |