510(k) K061441 ยท MNH Orthosis, Spondylolisthesis Spinal Fixation
EBI 5.5 HELICAL FLANGE SPINAL SYSTEM
| Applicant | Ebi, L.P., Parsippany NJ, US |
| Decision | Substantially Equivalent, Jul 25, 2006 |
| Received | May 24, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061441
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 22, 2009 | EBI, L.P. Cannulated Screw Ballista Percutaneous Pedicle Screw System. 6/5 x 45MM;
Biomet Spine, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in Terminated |
HSB | None listed |
| Sep 22, 2009 | EBI, L.P. C-Tek Maxan Anterior Cervical Plate System;
4.0MM X 20MM Fixed Screw'
Biomet Spine, 100 Interpace Parkway, Parsippany, NJ 07054
The screw devices are an internal fixation device intended to aid in th Terminated |
HSB | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.