The following data is part of a premarket notification filed by International Advanced Medical Enterprises, Inc. with the FDA for Haider-ucr Spinal System.
| Device ID | K993503 |
| 510k Number | K993503 |
| Device Name: | HAIDER-UCR SPINAL SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf INTERNATIONAL ADVANCED MEDICAL ENTERPRISES, INC. 200 GREGORY LN. SUITE C-100 Pleasant Hill, CA 94523 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-10-15 |
| Decision Date | 2000-04-14 |
| Summary: | summary |