510(k) K955848 ยท JDW Pin, Fixation, Threaded
ORTHOFIX MODULSYSTEM
| Applicant | Orthofix, Inc., Rockville MD, US |
| Decision | Substantially Equivalent, Mar 20, 1996 |
| Received | Dec 27, 1995 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K955848
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-91600UE, UE XCALIBER METADIAPHYSEAL COMPLETE KIT, RX ONLY, UDI: (01)18032937169696 Terminated |
JDW | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-91647, US XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937167791 Terminated |
JDW | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-91647UE, UE XCALIBER ANKLE COMPLETE KIT, RX ONLY, UDI: (01)18032937169719 Terminated |
JDW | None listed |
| 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 | None listed |
| 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 | None listed |
| 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 | None listed |
| Sep 27, 2018 | Orthofix Srl ORTHOFIX Catalogue Number: ref: 99-92504, PREFIX II ANKLE COMPLETE KIT STERILE, RX ONLY, UDI: (01)18033509855979 Terminated |
JDW | None listed |
| Apr 28, 2010 | Orthofix Srl Orthofix US XCaliber Meta-Diaphyseal Complete Kit, Sterile. 99-91600, manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy.
Intended for use in the treatment of bone condit Terminated |
JDW | None listed |
| Apr 28, 2010 | Orthofix Srl Orthofix US XCaliber Ankle Complete Kit, Sterile, 99-91647. manufactured by Orthofix SRL, Via delle Nazioni, 9, 27012 Bussolengo (VR) Italy.
Intended for use in the treatment of bone conditions inclu Terminated |
JDW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.