510(k) K001238 ยท JEY Plate, Bone
LORENZ TITANIUM FRACTURE / RECONSTRUCTION PLATING SYSTEM
| Applicant | Walter Lorenz Surgical, Inc., Jacksonville FL, US |
| Decision | Substantially Equivalent, May 3, 2000 |
| Received | Apr 18, 2000 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K001238
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 4, 2008 | Biomet Microfixation, Inc. HT X-DRIVE SCREW, Part # 91-2416, W.Lorenz Surgical. Screws for use in the stabilization and fixation of mandibular fractures and mandibular reconstructive surgical procedures. Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.