The following data is part of a premarket notification filed by Iame, Inc. with the FDA for Ucr Spinal System, 5.5mm, 8.0mm Screws & Instruments.
| Device ID | K021623 |
| 510k Number | K021623 |
| Device Name: | UCR SPINAL SYSTEM, 5.5MM, 8.0MM SCREWS & INSTRUMENTS |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | IAME, INC. 200 GREGORY LANE, SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Contact | David W Schlerf |
| Correspondent | David W Schlerf IAME, INC. 200 GREGORY LANE, SUITE C-100 Pleasant Hill, CA 94523 -3389 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-05-16 |
| Decision Date | 2002-09-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10889981062699 | K021623 | 000 |
| 10889981062682 | K021623 | 000 |
| 10889981062675 | K021623 | 000 |