The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Avs As Peek Spacer.
| Device ID | K142251 |
| 510k Number | K142251 |
| Device Name: | AVS AS PEEK Spacer |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Stryker Corporation 2 Pearl Court Stryker Spine Division Allendale, NJ 07401 |
| Contact | Garry T Hayeck |
| Correspondent | Garry T Hayeck Stryker Corporation 2 Pearl Court Stryker Spine Division 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 | 2014-08-14 |
| Decision Date | 2014-11-19 |
| Summary: | summary |