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 |