EXPEDIUM 186261445

GUDID 10705034115627

EXPEDIUM SPINE SYSTEM ROD, STRAIGHT (WITH HEX ENDS) 4.5 x 450mm

DEPUY SPINE, LLC

Bone-screw internal spinal fixation system rod
Primary Device ID10705034115627
NIH Device Record Key6f1d0830-9494-4560-b462-dd6ff969acf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameEXPEDIUM
Version Model Number186261445
Catalog Number186261445
Company DUNS107105876
Company NameDEPUY SPINE, LLC
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx
Phone+1(800)255-2500
Emailxx@xx.xx

Device Identifiers

Device Issuing AgencyDevice ID
GS110705034115627 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


[10705034115627]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2024-07-23
Device Publish Date2015-09-24

On-Brand Devices [EXPEDIUM]

10705034144986EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 6 x 45mm
10705034144979EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 6 x 40mm
10705034144962EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 6 x 35mm
10705034144955EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 6 x 30mm
10705034144825EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 50mm
10705034144818EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 45mm
10705034144801EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 40mm
10705034144795EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 35mm
10705034144788EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 30mm
10705034144771EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 5 x 25mm
10705034144641EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 45mm
10705034144634EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 40mm
10705034144627EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 35mm
10705034144610EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 30mm
10705034144603EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 25mm
10705034144597EXPEDIUM SPINE SYSTEM MONOAXIAL SCREW 5.5 x 4.35 x 20mm
10705034200880EXPEDIUM SPINE SYSTEM TAB KEY FOR EXTENDED TAB SCREWS 6.35
10705034303123EXPEDIUM SPINE SYSTEM OUTER NUT INSERTER 4.5
10705034224572EXPEDIUM SPINE SYSTEM CROSS-CONNECTOR INSERTER
10705034211541EXPEDIUM SPINE SYSTEM EXTENDED TANDEM CONNECTOR DISTRACTOR
10705034211527EXPEDIUM SPINE SYSTEM IN-LINE APPROXIMATOR INSERTER
10705034211466EXPEDIUM SPINE SYSTEM DISTRACTOR
10705034211305EXPEDIUM SPINE SYSTEM EXTENDED TAB REMOVER
10705034211183EXPEDIUM SPINE SYSTEM NUT INSERTER, CASTLE DRIVE
10705034211169EXPEDIUM SPINE SYSTEM INTERMEDIATE TIGHTENER x20
10705034211121EXPEDIUM SPINE SYSTEM FINAL TIGHTENER x20
10705034211091EXPEDIUM SPINE SYSTEM SINGLE INNIE INSERTER
10705034203270EXPEDIUM SPINE SYSTEM DEROTATION FLEX CLIP INSERT 5.5
10705034201184EXPEDIUM SPINE SYSTEM INSERTER
10705034201061EXPEDIUM SPINE SYSTEM LATERAL REDUCTION INSERTER, 6.35 X25 370mm
10705034201023EXPEDIUM SPINE SYSTEM VERTEBRAL-BODY ROTATION TUBE FOR CLIP-ON DEVICE 6.35
10705034201009EXPEDIUM SPINE SYSTEM SI SET SCREW INSERTER FOR CLIP-ON REDUCTION SLEEVE 6.35
10705034200903EXPEDIUM SPINE SYSTEM REDUCTION TAB REMOVER 6.35
10705034200897EXPEDIUM SPINE SYSTEM TAB RING FOR EXTENDED TAB SCREWS 6.35
10705034200750EXPEDIUM SPINE SYSTEM DISTRACTOR, PARALLEL ACTION 6.35
10705034200705EXPEDIUM SPINE SYSTEM INSERTER x25
10705034199283EXPEDIUM SPINE SYSTEM DUAL INNER INSERTER
10705034199061EXPEDIUM SPINE SYSTEM LATERAL REDUCTION INSERTER, 5.5 X25 370mm
10705034199016EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5mm
10705034198477EXPEDIUM SPINE SYSTEM DISTRACTOR, PARALLEL ACTION
10705034198408EXPEDIUM SPINE SYSTEM SINGLE INNER INSERTER 5.5
10705034199412EXPEDIUM SPINE SYSTEM DRIVER SLEEVE EXTENDED DI 5.5
10705034211282EXPEDIUM SPINE SYSTEM EXTENDED TAB KEY
10705034152820EXPEDIUM SPINE SYSTEM SIDE BY SIDE DUAL CONNECTOR 5.5 x 4.75mm
10705034116815EXPEDIUM SPINE SYSTEM SIDE-BY-SIDE EXTENDED 4 SCREW CONNECTOR 4.5 x 5.0mm
10705034116716EXPEDIUM SPINE SYSTEM SIDE-BY-SIDE EXTENDED 2 SCREW CONNECTOR 4.5 x 4.75mm
10705034153414EXPEDIUM SPINE SYSTEM SINGLE INLINE RODDED CONNECTOR 5.5 x 5.5-6.35 x 200mm
10705034152868EXPEDIUM SPINE SYSTEM SIDE BY SIDE DUAL CONNECTOR 5.5 x 6.35mm
10705034116587EXPEDIUM SPINE SYSTEM EXTENDED TANDEM CONNECTOR 4.5 - 4.5 x 80mm
10705034116570EXPEDIUM SPINE SYSTEM EXTENDED TANDEM CONNECTOR 4.5 - 4.5 x 60mm

Trademark Results [EXPEDIUM]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EXPEDIUM
EXPEDIUM
78421902 3072007 Live/Registered
DePuy Synthes, Inc.
2004-05-19

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.