The following data is part of a premarket notification filed by Spinalight, Inc with the FDA for Atlas Percussion Adjusting Instrument.
Device ID | K172536 |
510k Number | K172536 |
Device Name: | Atlas Percussion Adjusting Instrument |
Classification | Manipulator, Plunger-like Joint |
Applicant | Spinalight, Inc 6721 23rd Street North St. Petersburg, FL 33702 |
Contact | Stanford Pierce |
Correspondent | Stanford Pierce Spinalight, Inc 6721 23rd Street North St. Petersburg, FL 33702 |
Product Code | LXM |
CFR Regulation Number | 510(k) Premarket Notification [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-08-22 |
Decision Date | 2018-06-20 |
Summary: | summary |