The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Avamax Vertebral Balloon, Avaflex Vertebral Balloon.
| Device ID | K162062 |
| 510k Number | K162062 |
| Device Name: | AVAmax Vertebral Balloon, AVAflex Vertebral Balloon |
| Classification | Arthroscope |
| Applicant | STRYKER CORPORATION 4100 E MILHAM AVE Kalamazoo, MI 49001 |
| Contact | Becky Ditty |
| Correspondent | Becky Ditty STRYKER CORPORATION 4100 E MILHAM AVE Kalamazoo, MI 49001 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-26 |
| Decision Date | 2016-11-01 |
| Summary: | summary |