The following data is part of a premarket notification filed by Depuy Acromed with the FDA for Monarch Spine System Commercially Pure Titanium Spinal Rod.
| Device ID | K021148 |
| 510k Number | K021148 |
| Device Name: | MONARCH SPINE SYSTEM COMMERCIALLY PURE TITANIUM SPINAL ROD |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Contact | Lisa Gilman |
| Correspondent | Lisa Gilman DEPUY ACROMED 325 PARAMOUNT DR. Raynham, MA 02767 -0350 |
| Product Code | MNH |
| Subsequent Product Code | KWP |
| Subsequent Product Code | MNI |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-04-10 |
| Decision Date | 2002-05-08 |
| Summary: | summary |