ClearanceBrief
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

CodeDeviceRecords
JEYPlate, Bone81
KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction4
FWPProsthesis, Chin, Internal3
FSMTray, Surgical, Instrument1
FTLMesh, Surgical, Polymeric1
GXPMethyl Methacrylate For Cranioplasty1
HWCScrew, Fixation, Bone1
LXHOrthopedic Manual Surgical Instrument1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
No clearances in this window.

Latest recalls

DateFirm and productCodeLinked 510(k)
Oct 8, 2015Stryker 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
FSMNone listed
Feb 11, 2015Stryker 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
FTLK040364
Feb 11, 2015Stryker 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
FWPK952677
Feb 11, 2015Stryker 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
FWPK952677
Feb 11, 2015Stryker 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
FWPK922489
Aug 26, 2013Stryker 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
GXPK060763
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1301, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1300, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1299, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1298, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 10 mm screw, REF SCR-1297, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1294, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1293, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1292, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1291, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1290, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 20 mm screw, REF SCR-1289, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 17 mm screw, REF SCR-1288, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 15 mm screw, REF SCR-1287, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 13 mm screw, REF SCR-1286, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 11 mm screw, REF SCR-1285, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 9 mm screw, REF SCR-1284, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 18 mm screw, REF SCR-1243, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 16 mm screw, REF SCR-1242, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 14 mm screw, REF SCR-1241, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 12 mm screw, REF SCR-1240, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 10 mm screw, REF SCR-1239, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
3.1 mm Inion CPS, 3.1 x 18 mm screw, REF SCR-1230, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
3.1 mm Inion CPS, 3.1 x 16 mm screw, REF SCR-1229, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
3.1 mm Inion CPS, 3.1 x 14 mm screw, REF SCR-1228, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
3.1 mm Inion CPS, 3.1 x 12 mm screw, REF SCR-1227, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
3.1 mm Inion CPS, 3.1 x 10 mm screw, REF SCR-1226, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 7 mm screw, REF SCR-1225, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS, 2.0 x 5 mm screw, REF SCR-1224, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
1.5 mm Inion CPS, 1.5 x 6 mm screw, REF SCR-1223, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
1.5 mm Inion CPS, 1.5 x 4 mm screw, REF SCR-1222, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
1.5 mm Inion CPS Baby, 1.5 x 6 mm screw, REF SCR-1221, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
1.5 mm Inion CPS Baby, 1.5 x 4 mm screw, REF SCR-1220, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 18 mm screw, REF SCR-1216, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 16 mm screw, REF SCR-1215, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 14 mm screw, REF SCR-1214, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 12 mm screw, REF SCR-1213, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 10 screw, REF SCR-1212, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS Baby, 2.0 x 7 mm screw, REF SCR-1211, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.0 mm Inion CPS Baby, 2.0 x 5 mm screw, REF SCR-1210, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.8 mm Inion CPS, 2.8 x 23 mm screw, REF SCR-1209, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 23 mm screw, REF SCR-1208, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 8 mm screw, REF SCR-1207, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
2.5 mm Inion CPS, 2.5 x 6 mm screw, REF SCR-1206, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed
Dec 16, 2010Stryker Craniomaxillofacial Division
1.5 mm Inion CPS Baby, X-plate, large, REF PLT-1062, sterile, Manufacturer, INION Oy, Finland.
Terminated
JEYNone listed

Newest 50 of 93.

Get alerts for these product codes