The following data is part of a premarket notification filed by Orthopedic Equipment Co., Inc. with the FDA for Outrigger Distraction Unit.
| Device ID | K781444 |
| 510k Number | K781444 |
| Device Name: | OUTRIGGER DISTRACTION UNIT |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | ORTHOPEDIC EQUIPMENT CO., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-08-23 |
| Decision Date | 1978-09-27 |