The following data is part of a premarket notification filed by Spinalight, Inc. with the FDA for Flexion Distraction Table.
| Device ID | K933622 |
| 510k Number | K933622 |
| Device Name: | FLEXION DISTRACTION TABLE |
| Classification | Table, Powered |
| Applicant | SPINALIGHT, INC. 320 A BELL PARK DR. Woodstock, GA 30188 |
| Contact | Martin Cirou |
| Correspondent | Martin Cirou SPINALIGHT, INC. 320 A BELL PARK DR. Woodstock, GA 30188 |
| Product Code | INQ |
| CFR Regulation Number | 890.3760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-19 |
| Decision Date | 1994-01-07 |