The following data is part of a premarket notification filed by Veran Medical Technologies, Inc. with the FDA for Spin Thoracic Navigation System.
| Device ID | K170023 |
| 510k Number | K170023 |
| Device Name: | SPiN Thoracic Navigation System |
| Classification | System, X-ray, Tomography, Computed |
| Applicant | Veran Medical Technologies, Inc. 1908 Innerbelt Business Center Dr St. Louis, MO 63114 |
| Contact | Scott Wrightstone |
| Correspondent | Scott Wrightstone Veran Medical Technologies, Inc. 1908 Innerbelt Business Center Dr St. Louis, MO 63114 |
| Product Code | JAK |
| CFR Regulation Number | 892.1750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-01-03 |
| Decision Date | 2017-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00815686021146 | K170023 | 000 |
| 10815686021181 | K170023 | 000 |
| 10815686021273 | K170023 | 000 |
| 00815686021283 | K170023 | 000 |
| 10815686021297 | K170023 | 000 |
| 10815686021303 | K170023 | 000 |
| 10815686021310 | K170023 | 000 |
| 00815686021153 | K170023 | 000 |
| 10815686021167 | K170023 | 000 |
| 10815686021198 | K170023 | 000 |
| 00815686021245 | K170023 | 000 |
| 00815686021252 | K170023 | 000 |
| 10815686021266 | K170023 | 000 |
| 00815686021214 | K170023 | 000 |
| 00815686021122 | K170023 | 000 |
| 00815686021139 | K170023 | 000 |
| 10815686021174 | K170023 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() SPIN THORACIC NAVIGATION SYSTEM 88007821 5684517 Live/Registered |
Veran Medical Technologies, Inc. 2018-06-20 |