BIOSCREW XTRALOK C8041

GUDID 20845854013455

BIOSCREW XTRALOK 10MM X 40MM - VIOLET, BIOABSORBABLE INTERFERENCE SCREW, VIOLET

Conmed Corporation

Orthopaedic bone screw, bioabsorbable
Primary Device ID20845854013455
NIH Device Record Key66654d6d-4beb-4b7a-9ee4-bda3508c3643
Commercial Distribution StatusIn Commercial Distribution
Brand NameBIOSCREW XTRALOK
Version Model NumberC8041
Catalog NumberC8041
Company DUNS071595540
Company NameConmed Corporation
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Safe
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM
Phone+1(800)237-0169
EmailCUSTOMER_SERVICE@CONMED.COM

Device Dimensions

Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter
Length40 Millimeter
Outer Diameter10 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS120845854013455 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HWCScrew, fixation, bone

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2015-10-24

On-Brand Devices [BIOSCREW XTRALOK]

20845854014377BIOSCREW XTRALOK 8 X 35MM - VIOLET, BIOABSORBABLE INTERFERENCE SCREW, VIOLET
20845854014162BIOSCREW XTRALOK 10MM X 35MM - VIOLET BIOABSORBABLE INTERFERENCE SCREW, VIOLET
20845854013875BIOSCREW XTRALOK 11MM X 40MM - VIOLET, BIOABSORBABLE INTERFERENCE SCREW, VIOLET
20845854013868BIOSCREW XTRALOK 11MM X 35MM - VIOLET BIOABSORBABLE INTERFERENCE SCREW, VIOLET
20845854013790BIOSCREW XTRALOK 9MM X 35MM - VIOLET BIOABSORBABLE INTERFERENCE SCREW, VIOLET
20845854013493BIOSCREW XTRALOK 8 X 40MM - VIOLET, BIOABSORBABLE INTERFERENCE SCREW, VIOLET
20845854013455BIOSCREW XTRALOK 10MM X 40MM - VIOLET, BIOABSORBABLE INTERFERENCE SCREW, VIOLET
20845854013448BIOSCREW XTRALOK 9MM X 40MM - VIOLET, BIOABSORBABLE INTERFERENCE SCREW, VIOLET

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