Whistler Modular Pedicle Screw System WRC60300-T

GUDID 00195860001868

Ti Curved Rod, 6.0 Dia x 300 mm

Evolution Spine LLC

Bone-screw internal spinal fixation system rod
Primary Device ID00195860001868
NIH Device Record Keybd634974-1298-405e-9be9-eaa2fab3de86
Commercial Distribution StatusIn Commercial Distribution
Brand NameWhistler Modular Pedicle Screw System
Version Model NumberWRC60300-T
Catalog NumberWRC60300-T
Company DUNS116940934
Company NameEvolution 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(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com
Phone+1(214)682-8536
Emailinfo@evolutionspine.com

Device Dimensions

Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter
Length300 Millimeter
Outer Diameter6 Millimeter

Device Identifiers

Device Issuing AgencyDevice ID
GS100195860001868 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NKBThoracolumbosacral pedicle screw system

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

[00195860001868]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-05-25
Device Publish Date2021-05-17

On-Brand Devices [Whistler Modular Pedicle Screw System]

00195860000045Locking Cap, Solid, 6.0mm
00195860000038Locking Cap, Cannulated, 6.0 mm
00195860000021Locking Cap, Solid
00195860000014Locking Cap, Cannulated
00195860004579DIA 10.5 x 75mm, Solid, HA
00195860004432DIA 10.5 x 75mm, Solid
00195860004296DIA 9.5 x 75mm, Solid, HA
00195860004159DIA 9.5 x 75mm, Solid
00195860012239MIS Locking Cap Starter
00195860012222Tulip Inserter Forceps
00195860012567MIS Rod Caddy + Lid
00195860012550Open Rod Caddy + Lid
00195860012543Screw Caddy Lid
0019586001253610.5mm Screw Caddy
001958600125299.5mm Screw Caddy
001958600125128.5mm Screw Caddy
001958600125058.0mm Screw Caddy
001958600124997.5mm Screw Caddy
001958600124827.0mm Screw Caddy
001958600124756.5mm Screw Caddy
001958600124686.0mm Screw Caddy
001958600124515.5mm Screw Caddy
001958600124444.75mm Screw Caddy
00195860012437Tulip Caddy + Lid
00195860012420Solid Locking Cap Caddy + Lid
00195860012413Cannulated Locking Cap Caddy + Lid
00195860012406Rod Caddy + Lid
00195860012390Implant Case Lid
00195860012383Implant Case
00195860012376MODULAR REDUCTION TULIP INSERTER, THD, 8 INCH
00195860012369ROD ROCKER ASSEMBLY, LONG
00195860012352Screw Gauge
00195860012345FINAL TIGHTENING DRIVER, 8.5 INCH
00195860012338MIS ROD INSERTER
00195860005453Whistler Instrument Case 3 Tray 2
00195860005446Whistler Instrument Case 3 Tray 1
00195860005439Whistler Instrument Case 3 Lid
00195860005422Whistler Instrument Case 2 Tray 2
00195860005415Whistler Instrument Case 2 Tray 1
00195860005408Whistler Instrument Case 2 Lid
00195860005392Whistler Instrument Case 1 Tray 2
00195860005385Whistler Instrument Case 1 Tray 1
00195860005378Whistler Instrument Case 1 Lid
00195860005361Rod Gripper
00195860005354Ratcheting T-Handle
00195860005347Compressor
00195860005330Distractor
001958600053235.5mm Double Action Gripper
00195860005316Straight Ratcheting Handle
00195860005309Flexible Rod Template
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