The following data is part of a premarket notification filed by Stryker Spine with the FDA for Avs As Peek Spacer.
| Device ID | K120486 |
| 510k Number | K120486 |
| Device Name: | AVS AS PEEK SPACER |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Soraya King |
| Correspondent | Soraya King STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-17 |
| Decision Date | 2012-08-20 |
| Summary: | summary |