The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Stryker Spine Avs Pl Peek Spacers.
| Device ID | K082014 |
| 510k Number | K082014 |
| Device Name: | STRYKER SPINE AVS PL PEEK SPACERS |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Vikki M O'connor |
| Correspondent | Vikki M O'connor STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-07-15 |
| Decision Date | 2008-07-28 |
| Summary: | summary |