Panels › Orthopedic › Product code JDW · Class 2
Pin, Fixation, Threaded
Regulation 888.3040
1510(k)s in 12 months (94 all time)
0recalls in 12 months (100 all time)
73recalls that name a 510(k)
Top companies in JDW
| Company | 510(k)s | Recalls |
|---|---|---|
| Smith & Nephew, Inc. | 8 | 53 |
| Orthofix Srl | 2 | 23 |
| Zimmer, Inc. | 1 | 20 |
| Biomet, Inc. | 4 | 1 |
| Depuy, Inc. | 5 | 0 |
| Buckman Co., Inc. | 4 | 0 |
| Synthes (Usa) | 4 | 0 |
| Howmedica Corp. | 3 | 0 |
| O'Tec Corp. | 3 | 0 |
| Stryker Endoscopy | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-92503, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE LONG SCREWS, RX ONLY, UDI: (01)
18033509855962 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-92502,
PREFIX II DIAPHYSEAL COMPLETE KIT STERILE NO SCREWS, RX ONLY, UDI: (01) 18033509855955 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-92501, PREFIX II DIAPHYSEAL COMPLETE KIT STERILE SHORT SCREWS, RX ONLY, UDI: (01) 18033509855948 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-36501,
RADIOLUCENT WRIST FIXATOR KIT COMPLETE SYSTEM- STERILE, RX ONLY, UDI: (01)18032568861648 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1355001, DRILL BIT D.2,7 MM L.127 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242S10918 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1300301,DRILL BIT D.3,2 MM L.140 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18054242510901 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1100701,DRILL BIT D.4,8 MM L.280 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856099 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1100301,DRILL BIT Diameter 3.2 MM L. 200 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856075 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1100201,DRILL BIT Diameter .4,8 MM L.240 MM TIN COATED - QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18033509856068 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1-1100101,DRILL BIT Diameter 8 MM L.180 MM TIN COATED- QUICK CONNECT, RX ONLY, Non Sterile, UDI: (01)18032568039603 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1355001, drill bit diameter 2.7 MM LENGTH 127MM, RX ONLY, Non Sterile, UDI: (01)18032568033 137 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1100701, drill bit diameter 4.8 MM LENGTH 280MM, RX ONLY, Non Sterile, UDI: (01)18032568031966 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1100301, drill bit diameter 3.2 MM LENGTH 200 MM, RX ONLY, Non Sterile, UDI: (01)18032568031911 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1100201, drill bit diameter 4.8 MM LENGTH 240 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 1100101, drill bit diameter 4.8 MM LENGTH 180 MM, RX ONLY, Non Sterile, UDI: (01)18032568031867 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 13550, drill bit diameter 2.7 MM LENGTH 127 MM, RX ONLY, Non Sterile, UDI: (01)18032568033120 Terminated |
JDW | K955848 |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref 11007, drill bit diameter 4.8 MM LENGTH 280 MM, RX ONLY, Non Sterile, UDI: (01)18032568031959 Terminated |
JDW | K955848 |
| Jun 5, 2017 | Zimmer Biomet, Inc. Lateral Troch Plate Full Crimp - 254mm, model # 350838 Terminated |
JDW | K003294 |
| Jun 5, 2017 | Zimmer Biomet, Inc. Lateral Troch Plate Full Crimp - 254mm, model # 350837 Terminated |
JDW | K003294 |
| Jul 24, 2015 | Musculoskeletal Transplant Foundation, Inc. Cortical Pin 2.0 mm,Sterile, FREEZE DRIED: Store at ambient temperature. Do Not freeze. Terminated |
JDW | K061498 |
| Jun 6, 2012 | Smith & Nephew Inc 6.0 MM DIAMETER 50 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932962, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K023921 |
| Jun 6, 2012 | Smith & Nephew Inc 6.0 MM DIAMETER 40 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932961, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K023921 |
| Jun 6, 2012 | Smith & Nephew Inc 6.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932953, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K023921 |
| Jun 6, 2012 | Smith & Nephew Inc 6.0 MM DIAMETER 30 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932952, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K023921 |
| Jun 6, 2012 | Smith & Nephew Inc 6.0 MM DIAMETER 25 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932951, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K023921 |
| Jun 6, 2012 | Smith & Nephew Inc 5.0 MM DIAMETER 35 MM THREAD LENGTH EXTERNAL FIXATION HALF PIN HA TI-6AL-4V, REF 71932948, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K023921 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 5 MM X 70 MM SHORT HALF PIN TI-6AL-4V, REF 71055701, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | None listed |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 5 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71055551, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 5 MM X 50 MM SHORT HALF PIN TI-6AL-4V, REF 71055501, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | None listed |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 5 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71055401, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 5 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71055351, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 5 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71055301, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 5 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71055251, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 5 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71055201, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 70 MM SHORT HALF PIN TI-6AL-4V, REF 71056708, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 65 MM SHORT HALF PIN TI-6AL-4V, REF 71056658, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 60 MM SHORT HALF PIN TI-6AL-4V, REF 71056608, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 55 MM SHORT HALF PIN TI-6AL-4V, REF 71056558, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 50 MM SHORT HALF PIN TI-6AL-4V, REF 71056508, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 45 MM SHORT HALF PIN TI-6AL-4V, REF 71056458, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 40 MM SHORT HALF PIN TI-6AL-4V, REF 71056408, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 35 MM SHORT HALF PIN TI-6AL-4V, REF 71056358, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 30 MM SHORT HALF PIN TI-6AL-4V, REF 71056308, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 25 MM SHORT HALF PIN TI-6AL-4V, REF 71056258, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) 6 MM X 20 MM SHORT HALF PIN TI-6AL-4V, REF 71056208, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
| Jun 6, 2012 | Smith & Nephew Inc JET-X(R) BAR 5 MM X 45 MM BAR SHORT HALF PIN TI-6AL-4V, REF 71055451, QTY: (1), STERILE R, Smith & Nephew, Inc., Memphis, TN 38116
Orthopedic surgical device. Terminated |
JDW | K994143 |
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