The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Spira Open Matrix Alif And Llif.
| Device ID | K190483 |
| 510k Number | K190483 |
| Device Name: | SPIRA Open Matrix ALIF And LLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Camber Spine Technologies 501 Allendale Road King Of Prussia, PA 19406 |
| Contact | Erin Kriebel |
| Correspondent | Matthew Carey RQMIS, Inc. 110 Haverhill Road Amesbury, MA 01913 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-27 |
| Decision Date | 2019-09-23 |
| Summary: | summary |