The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Acculif Tl And Pl Cage.
| Device ID | K160715 |
| 510k Number | K160715 |
| Device Name: | AccuLIF TL And PL Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Aakash Jain |
| Correspondent | Tina Mornak STRYKER CORPORATION 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 | 2016-03-15 |
| Decision Date | 2016-07-08 |
| Summary: | summary |