The following data is part of a premarket notification filed by Osseus, Llc with the FDA for Osse-lign, 1.5mm Cocr And Ss Cable System And Components.
| Device ID | K040199 |
| 510k Number | K040199 |
| Device Name: | OSSE-LIGN, 1.5MM COCR AND SS CABLE SYSTEM AND COMPONENTS |
| Classification | Cerclage, Fixation |
| Applicant | OSSEUS, LLC 3131 PRINCETON PIKE BLDG. 5, SUITE 200 Lawrenceville, NJ 08648 |
| Contact | Shawn T Huxel |
| Correspondent | Shawn T Huxel OSSEUS, LLC 3131 PRINCETON PIKE BLDG. 5, SUITE 200 Lawrenceville, NJ 08648 |
| Product Code | JDQ |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-29 |
| Decision Date | 2004-02-20 |
| Summary: | summary |