510(k) K062789 ยท JEY Plate, Bone
SYNTHES (USA) RAPID RESORBABLE FIXATION SYSTEM
| Applicant | Synthes (Usa), West Chester PA, US |
| Decision | Substantially Equivalent, Feb 27, 2007 |
| Received | Sep 18, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K062789
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 7, 2016 | Synthes (USA) Products LLC 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 24 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.
Intended for use in frac Terminated |
JEY | None listed |
| Jun 7, 2016 | Synthes (USA) Products LLC 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 30 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.
Intended for use in fractu Terminated |
JEY | None listed |
| Jun 7, 2016 | Synthes (USA) Products LLC 1.5 mm Rapid Resorb Orbt1 F1 P1 w/Bending Template / 35 mm - Sterile, Rapid Resorbable Fixation System. 1.5 mm Rapid Resorbable Orbital Floor Plate with Bending Template.
Intended for use in fractu Terminated |
JEY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.