The following data is part of a premarket notification filed by American Medical Electronics, Inc. with the FDA for Ame(r) Rigid Fixation System.
| Device ID | K930531 |
| 510k Number | K930531 |
| Device Name: | AME(R) RIGID FIXATION SYSTEM |
| Classification | Appliance, Fixation, Spinal Interlaminal |
| Applicant | AMERICAN MEDICAL ELECTRONICS, INC. C/O BUCKMAN COMPANY 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf AMERICAN MEDICAL ELECTRONICS, INC. C/O BUCKMAN COMPANY 1000 BURNETT AVENUE, SUITE 250 Concord, CA 94520 |
| Product Code | KWP |
| CFR Regulation Number | 888.3050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-02 |
| Decision Date | 1994-02-01 |