510(k) K010352 ยท JEY Plate, Bone
CPS 1.5/2.0/2.5 BIOABSORBABLE FIXATION SYSTEM
| Applicant | Inion , Ltd., Tampere, FI |
| Decision | Substantially Equivalent, Mar 14, 2001 |
| Received | Feb 6, 2001 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K010352
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby, 4 hole plate, REF PLT-1000, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby , 20 hole plate, REF PLT-1001, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| May 7, 2010 | Stryker Craniomaxillofacial Division Inion 1.5 x 6mm CPS(R) Baby Screw, 1.5mm Inion CPS(R) Baby 5+E, REF SCR 1221, 5/pack, STERILE/R Stryker Craniomaxillofacial, Portage, MI.
The INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM is a cra Terminated |
HWC | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.