The following data is part of a premarket notification filed by Stryker Spine with the FDA for Avs Pl Peek Spacers, Models 48351xxx And 48353xxx.
| Device ID | K073470 |
| 510k Number | K073470 |
| Device Name: | AVS PL PEEK SPACERS, MODELS 48351XXX AND 48353XXX |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Simona Voic |
| Correspondent | Simona Voic STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Product Code | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-10 |
| Decision Date | 2008-03-06 |
| Summary: | summary |