The following data is part of a premarket notification filed by Izi Medical with the FDA for Osteo-site Vertebral Balloon.
| Device ID | K200763 |
| 510k Number | K200763 |
| Device Name: | Osteo-site Vertebral Balloon |
| Classification | Arthroscope |
| Applicant | IZI Medical 5 Easter Court, Suite J Owings Mills, MD 21117 |
| Contact | Qiang Cao |
| Correspondent | Qiang Cao IZI Medical 5 Easter Court, Suite J Owings Mills, MD 21117 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-24 |
| Decision Date | 2020-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815212024535 | K200763 | 000 |
| 00815212024399 | K200763 | 000 |
| 00815212024559 | K200763 | 000 |
| 00815212024542 | K200763 | 000 |
| 00815212026768 | K200763 | 000 |
| 00815212026881 | K200763 | 000 |
| 00815212026874 | K200763 | 000 |
| 00815212026904 | K200763 | 000 |
| 10815212026895 | K200763 | 000 |