The following data is part of a premarket notification filed by Spineworxx Ag with the FDA for Born Pt-lif Cage Ha.
| Device ID | K202380 |
| 510k Number | K202380 |
| Device Name: | Born PT-LIF Cage HA |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | SpineworxX AG Schuppisstrasse 10 St. Gallen, CH 9016 |
| Contact | Aouda Ouzzaa |
| Correspondent | Cassandra Petrov JALEX Medical 27865 Clemens Rd Suite 3 Westlake, OH 44145 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-20 |
| Decision Date | 2021-02-19 |