Whistler Pedicle Screw System WI-079

GUDID 00195860030028

Rod Caliper

Evolution Spine LLC

General-purpose calliper, metallic
Primary Device ID00195860030028
NIH Device Record Keyb075e922-e985-409a-a991-5e50c62c747f
Commercial Distribution StatusIn Commercial Distribution
Brand NameWhistler Pedicle Screw System
Version Model NumberWI-079
Catalog NumberWI-079
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 Usefalse
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)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com
Phone+1(214)281-8871
Emailinfo@evolutionspine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100195860030028 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LXHOrthopedic manual surgical instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-09-08
Device Publish Date2025-08-29

Devices Manufactured by Evolution Spine LLC

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00195860029947 - E3D®-C Interbody System2025-09-16 SHORT FIXED ANGLE DRILL TIP 12MM
00195860029954 - E3D®-C Interbody System2025-09-16 E3D-C TRIAL TRAY TOP LEVEL INSERT
00195860029961 - E3D®-C Interbody System2025-09-16 E3D-C INTEGRATED INSTRUMENTS MIDDLE LEVEL INSERT
00195860029978 - E3D®-C Interbody System2025-09-16 E3D-C INTEGRATED INSTRUMENTS AND IMPLANTS BOTTOM LEVEL TRAY
00195860029985 - E3D®-C Interbody System2025-09-16 E3D-C INSTRUMENTS TRAY LID
00195860029992 - E3D®-C Interbody System2025-09-16 E3D-C DRILL AND DRIVER CADDY
00195860030004 - E3D®-C Interbody System2025-09-16 E3D-C STATIC INSTRUMENTS BOTTOM LEVEL TRAY

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