The following data is part of a premarket notification filed by Spinalight, Inc. with the FDA for Model 8000 Atlas C-1 Orthogonal Adjusting Instrument.
| Device ID | K946258 |
| 510k Number | K946258 |
| Device Name: | MODEL 8000 ATLAS C-1 ORTHOGONAL ADJUSTING INSTRUMENT |
| Classification | Manipulator, Plunger-like Joint |
| Applicant | SPINALIGHT, INC. 320-A BELL PARK DR. Woodstock, GA 30188 -1661 |
| Contact | T A Cox |
| Correspondent | T A Cox SPINALIGHT, INC. 320-A BELL PARK DR. Woodstock, GA 30188 -1661 |
| 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 | 1994-12-06 |
| Decision Date | 1995-11-20 |