The following data is part of a premarket notification filed by Stryker Corp. with the FDA for Avs Align Peek Spacers Model 48328xxx, 48326xxx.
| Device ID | K093864 |
| 510k Number | K093864 |
| Device Name: | AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | STRYKER CORP. 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Kimberly S Lane |
| Correspondent | Kimberly S Lane 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 | 2009-12-17 |
| Decision Date | 2010-03-11 |
| Summary: | summary |