EVOL®SI Joint Fusion System

GUDID 00841193124995

EVOL®SI Stackable Steinmann Pin, 3.2 Blunt End

Cutting Edge Spine, LLC

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Primary Device ID00841193124995
NIH Device Record Key8af9dd9d-b8d2-4e80-a986-3ba6f5b95520
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVOL®SI Joint Fusion System
Version Model NumberCES-318
Company DUNS069472647
Company NameCutting Edge Spine, LLC
Device Count1
DM Exempttrue
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone7042430892
Emailb.roof@cuttingedgespine.com
Phone7042430892
Emailb.roof@cuttingedgespine.com
Phone7042430892
Emailb.roof@cuttingedgespine.com
Phone7042430892
Emailb.roof@cuttingedgespine.com
Phone7042430892
Emailb.roof@cuttingedgespine.com
Phone7042430892
Emailb.roof@cuttingedgespine.com
Phone7042430892
Emailb.roof@cuttingedgespine.com
Phone7042430892
Emailb.roof@cuttingedgespine.com
Phone7042430892
Emailb.roof@cuttingedgespine.com
Phone7042430892
Emailb.roof@cuttingedgespine.com
Phone7042430892
Emailb.roof@cuttingedgespine.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100841193124995 [Primary]

FDA Product Code

OURSacroiliac Joint Fixation

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841193124995]

Moist Heat or Steam Sterilization

[00841193124995]

Moist Heat or Steam Sterilization

[00841193124995]

Moist Heat or Steam Sterilization

[00841193124995]

Moist Heat or Steam Sterilization

[00841193124995]

Moist Heat or Steam Sterilization

[00841193124995]

Moist Heat or Steam Sterilization

[00841193124995]

Moist Heat or Steam Sterilization

[00841193124995]

Moist Heat or Steam Sterilization

[00841193124995]

Moist Heat or Steam Sterilization

[00841193124995]

Moist Heat or Steam Sterilization

[00841193124995]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-05-06
Device Publish Date2024-04-26

On-Brand Devices [EVOL®SI Joint Fusion System]

00841193122991EVOL®SI, 11.5mm Washer
00841193122984EVOL®SI, 10.5mm Washer
00841193122977EVOL®SI, 9.5mm Washer
00841193122960EVOL®SI, 7.5mm Washer
0084119312295311.5mm x 060mm EVOL®SI Screw
0084119312294611.5mm x 055mm EVOL®SI Screw
0084119312293911.5mm x 050mm EVOL®SI Screw
0084119312292211.5mm x 045mm EVOL®SI Screw
0084119312291511.5mm x 040mm EVOL®SI Screw
0084119312290811.5mm x 035mm EVOL®SI Screw
0084119312289211.5mm x 030mm EVOL®SI Screw
0084119312288511.5mm x 025mm EVOL®SI Screw
0084119312287810.5mm x 060mm EVOL®SI Screw
0084119312286110.5mm x 055mm EVOL®SI Screw
0084119312285410.5mm x 050mm EVOL®SI Screw
0084119312284710.5mm x 045mm EVOL®SI Screw
0084119312283010.5mm x 040mm EVOL®SI Screw
0084119312282310.5mm x 035mm EVOL®SI Screw
0084119312281610.5mm x 030mm EVOL®SI Screw
0084119312280910.5mm x 025mm EVOL®SI Screw
008411931227939.5mm x 060mm EVOL®SI Screw
008411931227869.5mm x 055mm EVOL®SI Screw
008411931227799.5mm x 050mm EVOL®SI Screw
008411931227629.5mm x 045mm EVOL®SI Screw
008411931227559.5mm x 040mm EVOL®SI Screw
008411931227489.5mm x 035mm EVOL®SI Screw
008411931227319.5mm x 030mm EVOL®SI Screw
008411931227249.5mm x 025mm EVOL®SI Screw
008411931227177.5mm x 060mm EVOL®SI Screw
008411931227007.5mm x 055mm EVOL®SI Screw
008411931226947.5mm x 050mm EVOL®SI Screw
008411931226877.5mm x 045mm EVOL®SI Screw
008411931226707.5mm x 040mm EVOL®SI Screw
008411931226637.5mm x 035mm EVOL®SI Screw
00841193122656EVOL®SI, Power Adapter, 1/4" Sq to Jacobs
00841193122649EVOL®SI, Axial, Ratchet Handle, 1/4" Sq
00841193122632EVOL®SI, T-Handle, Ratchet, 1/4" Sq
00841193122625EVOL®SI, Radiolucent Wire Clamp
00841193122618EVOL®SI, 2.4mm Temporary K-Wire
00841193122601EVOL®SI, Bone Pusher
00841193122595EVOL®SI, Bone Funnel
00841193122588EVOL®SI, Insertion Sleeve (Large)
00841193122571EVOL®SI, Down-biting, Serrated Curette
00841193122564EVOL®SI, Up-biting, Serrated Curette
00841193122557EVOL®SI, Screwdriver (T40 Solid)
00841193122540EVOL®SI, Screwdriver (T40 Cannulated)
00841193122533EVOL®SI, 11.5mm Cannulated Tap
00841193122526EVOL®SI, 10.5mm Cannulated Tap
00841193122519EVOL®SI, 9.5mm Cannulated Tap
00841193122502EVOL®SI, 7.5mm Cannulated Tap

Trademark Results [EVOL]

Mark Image

Registration | Serial
Company
Trademark
Application Date
EVOL
EVOL
98173564 not registered Live/Pending
Evol, LLC
2023-09-11
EVOL
EVOL
98173554 not registered Live/Pending
Evol, LLC
2023-09-11
EVOL
EVOL
98173548 not registered Live/Pending
Evol, LLC
2023-09-11
EVOL
EVOL
98173544 not registered Live/Pending
Evol, LLC
2023-09-11
EVOL
EVOL
98173540 not registered Live/Pending
Evol, LLC
2023-09-11
EVOL
EVOL
98173532 not registered Live/Pending
Evol, LLC
2023-09-11
EVOL
EVOL
98066073 not registered Live/Pending
Shenzhen Qsun Industrial Co., Ltd.
2023-06-30
EVOL
EVOL
98012112 not registered Live/Pending
Shenzhen Qsun Industrial Co., Ltd.
2023-05-24
EVOL
EVOL
97851676 not registered Live/Pending
Jalen Cade Johnson
2023-03-22
EVOL
EVOL
97496795 not registered Live/Pending
Air Evol LLC
2022-07-11
EVOL
EVOL
90546499 not registered Live/Pending
Active Sports, Inc.
2021-02-25
EVOL
EVOL
90092961 not registered Live/Pending
May Hedge Capital, LLC
2020-08-04
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