The following data is part of a premarket notification filed by Spinalight, Inc. with the FDA for Hand Held Atlas Instrument.
| Device ID | K955540 |
| 510k Number | K955540 |
| Device Name: | HAND HELD ATLAS INSTRUMENT |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | SPINALIGHT, INC. 320 A BELL PARK DR. Woodstock, GA 30188 |
| Contact | T. A. Cox |
| Correspondent | T. A. Cox SPINALIGHT, INC. 320 A BELL PARK DR. Woodstock, GA 30188 |
| 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 | 1995-12-05 |
| Decision Date | 1996-03-04 |