The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Aero-al Lumbar Cage System.
| Device ID | K133328 |
| 510k Number | K133328 |
| Device Name: | AERO-AL LUMBAR CAGE SYSTEM |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Tiffani Rogers |
| Correspondent | Tiffani Rogers STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | OVD |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-29 |
| Decision Date | 2014-05-30 |