The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Avs Pl Peek Spacers, Models 48351 And 48353.
| Device ID | K080758 |
| 510k Number | K080758 |
| Device Name: | AVS PL PEEK SPACERS, MODELS 48351 AND 48353 |
| 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 | 2008-03-18 |
| Decision Date | 2008-03-27 |
| Summary: | summary |