Panels › Orthopedic › Product code JDQ · Class 2
Cerclage, Fixation
Regulation 888.3010
1510(k)s in 12 months (130 all time)
0recalls in 12 months (15 all time)
11recalls that name a 510(k)
Top companies in JDQ
| Company | 510(k)s | Recalls |
|---|---|---|
| Pioneer Surgical Technology | 13 | 1 |
| Howmedica Corp. | 8 | 0 |
| Synthes (Usa) | 8 | 0 |
| Alto Development Corp | 0 | 5 |
| Smith & Nephew, Inc. | 3 | 2 |
| A & E Medical Corporation | 4 | 0 |
| Pioneer Surgical Technology, Inc. (Dba Rti Surgical, Inc.) | 4 | 0 |
| Acu Med, Inc. | 3 | 0 |
| Arthrex, Inc. | 3 | 0 |
| Biodynamic Technologies, Inc. | 3 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 10, 2019 | Alto Development Corp A&E Medical Thorecon Plating System Kits Model No. 94-1700-10. For fracture fixation or reconstruction of the sternum. Terminated |
JDQ | K181607 |
| Sep 10, 2019 | Alto Development Corp A&E Medical Thorecon Plating System Kits Model No. 94-1500-04-S. For fracture fixation or reconstruction of the sternum. Terminated |
JDQ | K181607 |
| Sep 10, 2019 | Alto Development Corp A&E Medical Thorecon Plating System Kits Model No. 94-1400-04. For fracture fixation or reconstruction of the sternum. Terminated |
JDQ | K181607 |
| Sep 10, 2019 | Alto Development Corp A&E Medical Thorecon Plating System Kits Model No. 94-1300-04-S. For fracture fixation or reconstruction of the sternum. Terminated |
JDQ | K181607 |
| Sep 10, 2019 | Alto Development Corp A&E Medical Thorecon Plating System Kits Model No. 94-1200-08. For fracture fixation or reconstruction of the sternum. Terminated |
JDQ | K181607 |
| Nov 14, 2015 | Synthes (USA) Products LLC Synthes Application Instrument for Sternal ZIPFIX. Indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the ste Terminated |
JDQ | K110789 |
| Aug 27, 2015 | Synthes (USA) Products LLC Synthes Application Instrument for Sternal ZIPFIX; indications for use include primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the stern Terminated |
JDQ | K110789 |
| Jul 24, 2015 | EXP Pharmaceutical Services Corp Medical Device Exchange 3.5mm Threaded Cerclage Pin;
Pouch, Tyvek/Mylar, Sterile, Single Use Only;
OEM Catalog number 298.838S;
EXP (repackager), Synthes (OEM)
Cerclage, fixation Terminated |
JDQ | None listed |
| Jul 9, 2015 | RTI Surgical, Inc. (dba Pioneer Surgical Technology, Inc.) Songer Spinal Cable System, Single Cable, Crimp, Bar, Stainless Steel, Sterile.
The DePuy Spine Cable System can be utilized anywhere monofilament wire has been previously found to be indicated. Terminated |
JDQ | None listed |
| Jul 17, 2014 | PIONEER SURGICAL TECHNOLOGY, INC. Tritium Sternal Plate System, Screw, 02.7mm X 12mm, 12 Pack, Sterile.
The Pioneer Surgical Cable Plate System is used in the stabilization and fixation of fractures of the anterior chest wall incl Terminated |
JDQ | K133785 |
| Oct 30, 2013 | Synthes USA HQ, Inc. Synthes Application Instrument Sternal Zip Flex System
intended for use in primary or secondary closure/repair of the sternum following sternotomy or fracture of the sternum to stabilize the sternum Terminated |
JDQ | K110789 |
| Aug 10, 2010 | Smith & Nephew Inc CERCLAGE WIRE, 0.8 MM DIA. X 200 MM LENGTH, SST, REF 71163008, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Ge Terminated |
JDQ | None listed |
| Aug 10, 2010 | Smith & Nephew Inc CERCLAGE WIRE, 0.6 MM DIA. X 175 MM LENGTH, SST, REF 71163006, QTY: (6), STERILE R, CE 008, 2020/07, Smith & Nephew, Inc., Memphis, TN 38116, EC REP: Smith & Nephew Orthopaedics GmbH, Tuttlingen, Ge Terminated |
JDQ | None listed |
| Nov 9, 2008 | Biomet, Inc. Biomet 2.0 MM Stainless Steel (SS) Crimp Sleeve, sterile, use w/2.0 MM S.S. cable # 350800, Biomet Orthopedics, Inc., Warsaw, IN; REF. 350805.
Intended for general orthopedic repairs including long b Terminated |
JDQ | K982545 |
| Aug 22, 2008 | Acumed LLC Osteo-Clage Cable System Package Assembly (01-0001-S). Product labeled in part, "2.0mm x 850 mm CoCr Cable / Sleeve... REF 01-0001-S LOT W59192... Acumed 5885 NW Cornelius Pass Road Hilsboro, OR 9712 Terminated |
JDQ | K921480 |
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