The following data is part of a premarket notification filed by Camber Spine Technologies Llc with the FDA for Spira Open Matrix Llif.
| Device ID | K180724 |
| 510k Number | K180724 |
| Device Name: | SPIRA Open Matrix LLIF |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Camber Spine Technologies LLC 418 E. Lancaster Ave. Wayne, PA 19087 |
| Contact | Sean S. Bishop |
| Correspondent | Barry Sands RQMIS, Inc. 110 Haverhill Road, Suite 526 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 | 2018-03-20 |
| Decision Date | 2018-06-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B030SPL226015080 | K180724 | 000 |
| B030SPL225515080 | K180724 | 000 |
| B030SPL225015080 | K180724 | 000 |
| B030SPL224515080 | K180724 | 000 |
| B030SPL224015080 | K180724 | 000 |