The following data is part of a premarket notification filed by American Medical Electronics, Inc. with the FDA for Ame Universal Bone Screw.
| Device ID | K930107 |
| 510k Number | K930107 |
| Device Name: | AME UNIVERSAL BONE SCREW |
| Classification | Screw, Fixation, Bone |
| Applicant | AMERICAN MEDICAL ELECTRONICS, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Contact | Rebecca S White |
| Correspondent | Rebecca S White AMERICAN MEDICAL ELECTRONICS, INC. 250 EAST ARAPAHO RD. Richardson, TX 75081 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-11 |
| Decision Date | 1994-02-22 |