The following data is part of a premarket notification filed by Stryker Spine with the FDA for Tritanium X Pl Expandable Posterior Lumbar Cage, Tritanium X Tl Expandable Curved Posterior Lumbar Cage.
| Device ID | K183249 |
| 510k Number | K183249 |
| Device Name: | Tritanium X PL Expandable Posterior Lumbar Cage, Tritanium X TL Expandable Curved Posterior Lumbar Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | STRYKER SPINE 2 Pearl Court Allendale, NJ 07401 |
| Contact | Deirdre Jayko |
| Correspondent | Deirdre Jayko Stryker 2 Pearl Court Allendale, NJ 07401 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-11-21 |
| Decision Date | 2019-07-25 |
| Summary: | summary |