510(k) K030069 ยท JEY Plate, Bone
SYNTHES POLY (L-LACTIDE-CO-GLYCOLIDE) RESORBABLE FIXATION SYSTEM
| Applicant | Synthes (Usa), Paoli PA, US |
| Decision | Substantially Equivalent, Apr 8, 2003 |
| Received | Jan 8, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K030069
| 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.