510(k) K014263 ยท JEY Plate, Bone
NEWGEN/UNIVERSAL MANDIBULAR SYSTEM
| Applicant | Stryker Instruments, Kalamazoo MI, US |
| Decision | Substantially Equivalent, Mar 8, 2002 |
| Received | Dec 27, 2001 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K014263
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 30, 2008 | Stryker Leibinger USA Stryker Leibinger New Generation/Universal Mandibular System, Mand. Recon Plate, Straight, w. Template, Stryker Leibinger GmbH & Co., Freiburg, Germany; REF # 55-28911.
A mandibular plate and screw Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.