The following data is part of a premarket notification filed by Roseburg Sa with the FDA for Universal Instrumentation(cd) For Spinal Surgery.
| Device ID | K872715 |
| 510k Number | K872715 |
| Device Name: | UNIVERSAL INSTRUMENTATION(CD) FOR SPINAL SURGERY |
| Classification | Implant, Fixation Device, Spinal |
| Applicant | ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Contact | Darienne Moyer |
| Correspondent | Darienne Moyer ROSEBURG SA SUITE 120 CANAL SQUARE 1054 31ST STREET NW Washington, DC 20007 |
| Product Code | JDN |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-07-10 |
| Decision Date | 1987-12-07 |