CosmoLock Pedicle Screw System

GUDID B07311K0140110

T-Handle, T30 Split Tip, Extended Assembly

Kalitec Direct LLC

Surgical screwdriver, reusable
Primary Device IDB07311K0140110
NIH Device Record Key1ac82e04-598c-46c8-9712-da93fd1c9e99
Commercial Distribution StatusIn Commercial Distribution
Brand NameCosmoLock Pedicle Screw System
Version Model Number11-K01-4011
Company DUNS041956211
Company NameKalitec Direct 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 Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB07311K0140110 [Primary]

FDA Product Code

HWDStarter, Bone Screw

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[B07311K0140110]

Moist Heat or Steam Sterilization

[B07311K0140110]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-10-22
Device Publish Date2018-09-19

On-Brand Devices [CosmoLock Pedicle Screw System]

BO7310SNE47551SCREW, CORTICAL, EXT TAB CANN, 4.75 X 55MM
BO7310SNE47451SCREW, CORTICAL, EXT TAB CANN, 4.75 X 45MM
B07311XLV00040Cross Connector, Adjustable, Small, 30-37mm
B07311XLV000350Crosslink Set Screw, Lrg
B07311XLV00030Cross Connector, Vari Lrg
B07311XLV000250Crosslink Set Screw, Med
B07311XLV00020Cross Connector, Vari Med
B07311XLV000150Crosslink Set Screw, Sml
B07311XLV00010Cross Connector, Vari Sml
B07311XLF00400Cross Connector, Fixed Arm, 40mm
B07311XLF00380Cross Connector, Fixed Arm, 38mm
B07311XLF00360Cross Connector, Fixed Arm, 36mm
B07311XLF00340Cross Connector, Fixed Arm, 34mm
B07311XLF00320Cross Connector, Fixed Arm, 32mm
B07311XLF00300Cross Connector, Fixed Arm, 30mm
B07311XLF00280Cross Connector, Fixed Arm, 28mm
B07311XLF00260Cross Connector, Fixed Arm, 26mm
B07311XLF00240Cross Connector, Fixed Arm, 24mm
B07311XLF00220Cross Connector, Fixed Arm, 22mm
B07311XLF00200Cross Connector, Fixed Arm, 20mm
B07311XLF00180Cross Connector, Fixed Arm, 18mm
B07311XLF00160Cross Connector, Fixed Arm, 16mm
B07311XLF00140Cross Connector, Fixed Arm, 14mm
B07311SSP75900Screw, 7.5x90mm Poly
B07311SSP75800Screw, 7.5x80mm Poly
B07311SSP75750Screw, 7.5x75mm Poly
B07311SSP75700Screw, 7.5x70mm Poly
B07311SSP75650Screw, 7.5x65mm Poly
B07311SSP75550Screw, 7.5x55mm Poly
B07311SSP75500Screw, 7.5x50mm Poly
B07311SSP75450Screw, 7.5x45mm Poly
B07311SSP75400Screw, 7.5x40mm Poly
B07311SSP75350Screw, 7.5x35mm Poly
B07311SSP75300Screw, 7.5x30mm Poly
B07311SSP75000Screw, 7.5x100mm Poly
B07311SSP65550Screw, 6.5x55mm Poly
B07311SSP65500Screw, 6.5x50mm Poly
B07311SSP65450Screw, 6.5x45mm Poly
B07311SSP65400Screw, 6.5x40mm Poly
B07311SSP65350Screw, 6.5x35mm Poly
B07311SSP65300Screw, 6.5x30mm Poly
B07311SSP55550Screw, 5.5x55mm Poly
B07311SSP55500Screw, 5.5x50mm Poly
B07311SSP55450Screw, 5.5x45mm Poly
B07311SSP55400Screw, 5.5x40mm Poly
B07311SSP55350Screw, 5.5x35mm Poly
B07311SSP55300Screw, 5.5x30mm Poly
B07311SSP55250Screw, 5.5x25mm Poly
B07311SSE75550Screw, Ext Tab 7.5x55mm Poly
B07311SSE75500Screw, Ext Tab 7.5x50mm Poly
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