The following data is part of a premarket notification filed by Custom Spine, Inc. with the FDA for Kompreda.
| Device ID | K120597 |
| 510k Number | K120597 |
| Device Name: | KOMPREDA |
| Classification | System, Facet Screw Spinal Device |
| Applicant | CUSTOM SPINE, INC. 9 Campus Dr Parsippany, NJ 07054 |
| Contact | David Brumfield |
| Correspondent | David Brumfield CUSTOM SPINE, INC. 9 Campus Dr Parsippany, NJ 07054 |
| Product Code | MRW |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-28 |
| Decision Date | 2013-05-03 |
| Summary: | summary |