The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Avs Al And Avs Align Peek Spacers, Avs Pl And Avs Unilif Peek Spacers, Avs Tl Peek Spacer, Avs Navigator Peek Spacer, Avs Aria Peek Spacer.
| Device ID | K151726 |
| 510k Number | K151726 |
| Device Name: | AVS AL And AVS ALign PEEK Spacers, AVS PL And AVS UniLIF PEEK Spacers, AVS TL PEEK Spacer, AVS Navigator PEEK Spacer, AVS ARIA PEEK Spacer |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | Stryker Corporation 2 Pearl Court Allendale, NJ 07401 |
| Contact | Garry T Hayeck |
| Correspondent | Kristen Meany 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 | 2015-06-26 |
| Decision Date | 2016-01-20 |
| Summary: | summary |