The following data is part of a premarket notification filed by Stryker Corporation with the FDA for Stryker Ivas Elite Inflatable Vertebral Augmentation System (stryker Ivas Elite Balloon Catheter).
| Device ID | K172116 |
| 510k Number | K172116 |
| Device Name: | Stryker IVAS Elite Inflatable Vertebral Augmentation System (Stryker IVAS Elite Balloon Catheter) |
| Classification | Arthroscope |
| Applicant | Stryker Corporation 4100 E. Milham Avenue Kalamazoo, MI 49001 |
| Contact | Kristi Ashton |
| Correspondent | Kristi Ashton Stryker Corporation 4100 E. Milham Avenue 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 | 2017-07-13 |
| Decision Date | 2018-01-25 |
| Summary: | summary |