FENESTRATED SCREWS

GUDID 18257200129133

8.5MM X 40MM JANUS FENESTRATED SCREW

ORTHOFIX INC.

Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile Bone-screw internal spinal fixation system, non-sterile
Primary Device ID18257200129133
NIH Device Record Key7f240716-ef12-43a5-8f46-f5481c16c28c
Commercial Distribution StatusIn Commercial Distribution
Brand NameFENESTRATED SCREWS
Version Model Number36-4840
Company DUNS927083808
Company NameORTHOFIX INC.
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 Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com
Phone+1(800)527-0404
Emailcustomerservice@orthofix.com

Device Identifiers

Device Issuing AgencyDevice ID
GS118257200129133 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

[18257200129133]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2019-03-20
Device Publish Date2019-03-12

On-Brand Devices [FENESTRATED SCREWS]

18257200133550ADAPTER WRENCH
18257200133543TALL ADAPTER
18257200133536SHORT ADAPTER
18257200133529ADAPTER INSERTER
18257200133512PLUNGER
18257200133505CANNULA
182572001334999.5MM CANULATED BONE TAP
182572001334828.5MM CANULATED BONE TAP
18257200133192JANUS FENESTRATED IMPLANT / INSTRUMENT TRAY KIT (36-9110)
182572001319526.5MM X 30MM JANUS HA COATED FENESTRATED SCREW, SP
182572001319454.5MM X 55MM JANUS HA COATED FENESTRATED SCREW, SP
182572001319384.5MM X 50MM JANUS HA COATED FENESTRATED SCREW, SP
182572001319214.5MM X 45MM JANUS HA COATED FENESTRATED SCREW, SP
182572001319144.5MM X 40MM JANUS HA COATED FENESTRATED SCREW, SP
182572001319074.5MM X 35MM JANUS HA COATED FENESTRATED SCREW, SP
182572001318914.5MM X 30MM JANUS HA COATED FENESTRATED SCREW, SP
182572001318844.5MM X 80MM JANUS FENESTRATED SCREW
182572001318774.5MM X 75MM JANUS FENESTRATED SCREW
182572001318604.5MM X 70MM JANUS FENESTRATED SCREW
182572001318534.5MM X 65MM JANUS FENESTRATED SCREW
182572001318464.5MM X 60MM JANUS FENESTRATED SCREW
182572001318394.5MM X 55MM JANUS FENESTRATED SCREW
182572001318224.5MM X 50MM JANUS FENESTRATED SCREW
182572001318154.5MM X 45MM JANUS FENESTRATED SCREW
182572001318084.5MM X 40MM JANUS FENESTRATED SCREW
182572001317924.5MM X 35MM JANUS FENESTRATED SCREW
182572001317854.5MM X 30MM JANUS FENESTRATED SCREW
18257200131754TALL ADAPTER CADDY
18257200131747SHORT ADAPTER CADDY
18257200131730CANNULA CADDY
18257200131723BOTTOM LEVEL, JANUS FENESTRATED IMPLANT & INSTRUMENT CASE
182572001317169.5MM JANUS FENESTRATED SCREW CADDY
182572001317098.5MM JANUS FENESTRATED SCREW CADDY
182572001316937.5MM JANUS FENESTRATED SCREW CADDY
182572001316866.5MM JANUS FENESTRATED SCREW CADDY
182572001316795.5MM JANUS FENESTRATED SCREW CADDY
182572001316624.5MM JANUS FENESTRATED SCREW CADDY
18257200131655TOP LEVEL, JANUS FENESTRATED IMPLANT & INSTRUMENT CASE
18257200131648BASE, JANUS FENESTRATED IMPLANT & INSTRUMENT CASE
18257200131631JANUS FENESTRATED IMPLANT & INSTRUMENT CASE
182572001298299.5MM X 55MM JANUS HA COATED FENESTRATED SCREW, SP
182572001298129.5MM X 50MM JANUS HA COATED FENESTRATED SCREW, SP
182572001298059.5MM X 45MM JANUS HA COATED FENESTRATED SCREW, SP
182572001297999.5MM X 40MM JANUS HA COATED FENESTRATED SCREW, SP
182572001297829.5MM X 35MM JANUS HA COATED FENESTRATED SCREW, SP
182572001297759.5MM X 30MM JANUS HA COATED FENESTRATED SCREW, SP
182572001297138.5MM X 55MM JANUS HA COATED FENESTRATED SCREW, SP
182572001297068.5MM X 50MM JANUS HA COATED FENESTRATED SCREW, SP
182572001296908.5MM X 45MM JANUS HA COATED FENESTRATED SCREW, SP
182572001296838.5MM X 40MM JANUS HA COATED FENESTRATED SCREW, SP
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