The following data is part of a premarket notification filed by Stryker Spine with the FDA for Ava Navigator Peek Spacers, Model 48392xxx, 48393xxx.
| Device ID | K100865 |
| 510k Number | K100865 |
| Device Name: | AVA NAVIGATOR PEEK SPACERS, MODEL 48392XXX, 48393XXX |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| Applicant | STRYKER SPINE 2 PEARL COURT Allendale, NJ 07401 |
| Contact | Kimberly S Lane |
| Correspondent | Kimberly S Lane 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 | 2010-03-29 |
| Decision Date | 2010-08-11 |
| Summary: | summary |