Company
Stryker Craniomaxillofacial Division
FDA 510(k) clearances and medical device recalls filed under this name. Name variants (Inc, Corp, punctuation) are merged.
0510(k) clearances (0 in 12 months)
93recalls (0 in 12 months)
12recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JEY | Plate, Bone | 81 |
| KKY | Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction | 4 |
| FWP | Prosthesis, Chin, Internal | 3 |
| FSM | Tray, Surgical, Instrument | 1 |
| FTL | Mesh, Surgical, Polymeric | 1 |
| GXP | Methyl Methacrylate For Cranioplasty | 1 |
| HWC | Screw, Fixation, Bone | 1 |
| LXH | Orthopedic Manual Surgical Instrument | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| No clearances in this window. | |||
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 8, 2015 | Stryker Craniomaxillofacial Division Disposable Paper Filter for Sterilization Containers
Paper, Medical Accessory, 100 DISP, Paper F, Steri.Cases, New Shape, Manufactured and distributed by Stryker Leibinger GmbH & Co KG, Distributed i Terminated |
FSM | None listed |
| Feb 11, 2015 | Stryker Craniomaxillofacial Division MEDPOR TITAN MAX Orbital Floor and Wall (OFW) MEDPOR-Titanium-Barrier (MTB) Right
Product Usage:
MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications Terminated |
FTL | K040364 |
| Feb 11, 2015 | Stryker Craniomaxillofacial Division MEDPOR BARRIER Sheets Rectangle
Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosmetic surgery Terminated |
FWP | K952677 |
| Feb 11, 2015 | Stryker Craniomaxillofacial Division MEDPOR BARRIER Sheets Orbital Floor Implant
Product Usage: MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weight-bearing applications of craniofacial reconstruction/cosm Terminated |
FWP | K952677 |
| Feb 11, 2015 | Stryker Craniomaxillofacial Division MEDPOR Surgical Implant Contoured Two Piece Chin 5 mm; Part Number 86001; Lot Numbers A1405048, A1404026
Product Usage:
MEDPOR Implants in block, sheet and pre-formed shapes are intended for non-weig Terminated |
FWP | K922489 |
| Aug 26, 2013 | Stryker Craniomaxillofacial Division Stryker Part Numbers 79-43903 (3cc), 79-43905 (5cc), 79-43910 (10 cc), 79-43915 (15cc), 397003 (3cc), 397005 (5cc), 397010 (10 cc), 397015 (15 cc) HydroSet Injectable HA Bone Substitute Sterile R/EO, Terminated |
GXP | K060763 |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1301, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1300, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1299, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 10 mm screw, REF SCR-1297, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1294, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1293, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1292, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1291, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1290, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 20 mm screw, REF SCR-1289, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 17 mm screw, REF SCR-1288, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 15 mm screw, REF SCR-1287, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 13 mm screw, REF SCR-1286, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 11 mm screw, REF SCR-1285, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 9 mm screw, REF SCR-1284, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1243, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1242, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1241, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1240, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1239, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 3.1 mm Inion CPS, 3.1 x 18 mm screw, REF SCR-1230, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 3.1 mm Inion CPS, 3.1 x 16 mm screw, REF SCR-1229, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 3.1 mm Inion CPS, 3.1 x 14 mm screw, REF SCR-1228, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 3.1 mm Inion CPS, 3.1 x 12 mm screw, REF SCR-1227, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 3.1 mm Inion CPS, 3.1 x 10 mm screw, REF SCR-1226, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 7 mm screw, REF SCR-1225, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 2.0 x 5 mm screw, REF SCR-1224, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, 1.5 x 6 mm screw, REF SCR-1223, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, 1.5 x 4 mm screw, REF SCR-1222, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby, 1.5 x 4 mm screw, REF SCR-1220, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1216, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1215, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1214, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1213, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 10 screw, REF SCR-1212, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS Baby, 2.0 x 7 mm screw, REF SCR-1211, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS Baby, 2.0 x 5 mm screw, REF SCR-1210, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.8 mm Inion CPS, 2.8 x 23 mm screw, REF SCR-1209, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 23 mm screw, REF SCR-1208, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 8 mm screw, REF SCR-1207, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 2.5 x 6 mm screw, REF SCR-1206, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby, X-plate, large, REF PLT-1062, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
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