Plate, Bone
Regulation 872.4760
5510(k)s in 12 months (294 all time)
0recalls in 12 months (111 all time)
27recalls that name a 510(k)
Top companies in JEY
| Company | 510(k)s | Recalls |
|---|---|---|
| Stryker Craniomaxillofacial Division | 0 | 81 |
| Synthes (Usa) | 42 | 2 |
| KLS Martin L.P. | 19 | 0 |
| Bioplate, Inc. | 16 | 2 |
| Walter Lorenz Surgical, Inc. | 15 | 3 |
| Biomet Microfixation | 8 | 7 |
| Stryker | 13 | 0 |
| Inion , Ltd. | 8 | 0 |
| Bionx Implants, Inc. | 7 | 0 |
| Medicon EG | 7 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby, 64 hole plate, REF PLT-1059, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 4 hole plate, extended long, REF PLT-1041, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, L-plate left, 7 holes, REF PLT-1040, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, L-plate right, 7 holes, REF PLT-1039, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 6 hole plate, REF PLT-1038, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, X-plate, 7 holes, REF PLT-1037, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 10 hole plate, REF PLT-1036, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, Mesh plate 14 x 14 holes, REF PLT-1035, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, Mesh plate 7 x 7 holes, REF PLT-1034, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, Mesh plate 14 x 14 holes, REF PLT-1033, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, Mesh plate 7 x7 holes, REF PLT-1032, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, Mesh plate 14 x 14 holes, REF PLT-1031, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, Mesh plate 7 x 7 10 holes, REF PLT-1030, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby, Mesh plate 14 x 14 holes, REF PLT-1029, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby, mesh plate 7 x 7 holes, REF PLT-1028, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 8 hole plate, REF PLT-1027, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 6 hole plate,extended, REF PLT-1026, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 6 hole plate, REF PLT-1025, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 4 hole plate, extended, REF PLT-1024, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.5 mm Inion CPS, 4 hole plate, REF PLT-1023, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, C-plate, 7 holes, REF PLT-1017, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 10 hole plate, REF PLT-1016, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 4-hole plate, extended, REF PLT-1014, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 2.0 mm Inion CPS, 4 hole plate, REF PLT-1013, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, X-plate, 7 holes, REF PLT-1012, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, Burrhole plate, REF PLT-1011, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, L-plate left, 7 holes, REF PLT-1010, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, L-plate right, 7 holes, REF PLT-1009, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, C-plate, 7 holes, REF PLT-1008, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, 20 hole plate, REF PLT-1007, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, 6 hole plate, REF PLT-1006, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS, 4 hole plate, REF PLT-1005, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby , 2 hole plate, REF PLT-1004, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby , X- plate 7 holes, REF PLT-1003, sterile, Manufacturer, INION Oy, Finland. Terminated |
JEY | None listed |
| Dec 16, 2010 | Stryker Craniomaxillofacial Division 1.5 mm Inion CPS Baby , C- plate 7 holes, REF PLT-1002, 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 | K010351 K010352 +1 |
| 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 | K010351 K010352 +1 |
| Oct 20, 2010 | Biomet Microfixation, Inc. 2.0/1.0 4 hole long plate (titanium plate ).Lot 120150.
Product labeling reads:
(1. ) REF: 01-9205, Lot 999999, " 2.0MM" SYSTEM PLATE 4 HOLE PLATE, STRAIGHT, LONG.
(2.) QTY 00001, CE 0086, *** Terminated |
JEY | K854886 |
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