The following data is part of a premarket notification filed by Stryker Spine with the FDA for Ascential Ibd Peekc Spacer.
| Device ID | K161407 |
| 510k Number | K161407 |
| Device Name: | Ascential IBD PEEKc Spacer |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| Applicant | Stryker Spine 2 Pearl Court Allendale, NJ 07401 |
| Contact | Tina Mornak |
| Correspondent | Tina Mornak Stryker Spine 2 Pearl Court Allendale, NJ 07401 |
| Product Code | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-20 |
| Decision Date | 2016-07-15 |
| Summary: | summary |