The following data is part of a premarket notification filed by Howmedica Osteonics with the FDA for Stryker Spine Maps System.
| Device ID | K032855 |
| 510k Number | K032855 |
| Device Name: | STRYKER SPINE MAPS SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Contact | Karen Ariemma |
| Correspondent | Karen Ariemma HOWMEDICA OSTEONICS 59 ROUTE 17 Allendale, NJ 07401 -1677 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-09-12 |
| Decision Date | 2003-12-10 |
| Summary: | summary |