The following data is part of a premarket notification filed by Camber Spine Technologies with the FDA for Enza-a Titanium Alif.
| Device ID | K173432 |
| 510k Number | K173432 |
| Device Name: | ENZA-A Titanium ALIF |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | Camber Spine Technologies 418 E. Lancaster Ave. Wayne, PA 19087 |
| Contact | Damian Heinz |
| Correspondent | Paul Speidel RQMIS, Inc. 110 Haverhill Road, Suite 526 Amesbury, MA 01913 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-02 |
| Decision Date | 2018-04-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B030EZA263209020 | K173432 | 000 |
| B030EZA263209010 | K173432 | 000 |