The following data is part of a premarket notification filed by American Medical Electronics, Inc. with the FDA for Ame Universal Fixation System.
| Device ID | K931381 |
| 510k Number | K931381 |
| Device Name: | AME UNIVERSAL FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | AMERICAN MEDICAL ELECTRONICS, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Contact | Keith Jung |
| Correspondent | Keith Jung AMERICAN MEDICAL ELECTRONICS, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-18 |
| Decision Date | 1995-02-01 |