The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Avs® Al And Align Peek Spacers, Avs® Pl And Unilif Peek Spacers, Avs® Tl Peek Spacer, Avs® Navigator Peek Spacer, Avs® Aria Peek Spacer, Acculif Tl And Pl Cage, Avs® Anchor-l Spacer, Aero-al Lumbar Cage System.
| Device ID | K143163 |
| 510k Number | K143163 |
| Device Name: | AVS® AL And ALign PEEK Spacers, AVS® PL And UniLIF PEEK Spacers, AVS® TL PEEK Spacer, AVS® Navigator PEEK Spacer, AVS® ARIA PEEK Spacer, AccuLIF TL And PL Cage, AVS® Anchor-L Spacer, Aero-AL Lumbar Cage System |
| Classification | Intervertebral Fusion Device With Integrated Fixation, Lumbar |
| Applicant | STRYKER CORPORATION 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Garry T Hayeck |
| Correspondent | Garry T Hayeck 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 | 2014-11-03 |
| Decision Date | 2015-01-26 |
| Summary: | summary |