EVOS Lumbar Interbody System CES-259

GUDID 00841193101545

EVOS Inserter Shaft

Cutting Edge Spine, LLC

Orthopaedic implant inserter/extractor, reusable
Primary Device ID00841193101545
NIH Device Record Keye2505127-c334-4f45-b743-871eabbc38a5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEVOS Lumbar Interbody System
Version Model NumberCES-259
Catalog NumberCES-259
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 Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com
Phone+1(704)243-0892
EmailB.Roof@cuttingedgespine.com

Device Dimensions

Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter
Length14 Millimeter

Operating and Storage Conditions

Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature
Special Storage Condition, SpecifyBetween 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing AgencyDevice ID
GS100841193101545 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MAXIntervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

[00841193101545]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-04-23
Device Publish Date2015-10-30

On-Brand Devices [EVOS Lumbar Interbody System]

00841193101545EVOS Inserter Shaft
00841193101521EVOS Rotate Only Inserter
00841193101514EVOS Non-Rotate Inserter
00841193122410Non-Cannulated, Large Hudson T-Handle
00841193122052Bayonet Box Curette, Straight
00841193122045Bayonet Box Curette, Angled
00841193122038Bayonet Cup Curette, Right, Small
00841193122021Bayonet Cup Curette, Left, Small
00841193122014Bayonet Cup Curette, Forward, Large
00841193122007Bayonet Cup Curette, Forward, Medium
00841193121994Bayonet Cup Curette, Forward, Small
00841193121987Bayonet Cup Curette, Reverse, Large
00841193121970Bayonet Cup Curette, Reverse, Medium
00841193121963Bayonet Cup Curette, Reverse, Small
00841193121956Bayonet Cup Curette, Straight, Large
00841193121949Bayonet Cup Curette, Straight, Medium
00841193121932Bayonet Cup Curette, Straight, Small
00841193122083Bayonet Rake Curette
00841193122076Bayonet Rasp, Straight
00841193122069Bayonet Rasp, Angled
00841193119908HA PEEK EVOS Straight, ,16mmx10mmx 26mm , FLAT 17 ° , Narrow Nose
00841193119892HA PEEK EVOS Straight, ,15mmx10mmx 26mm , FLAT 17 ° , Narrow Nose
00841193119885HA PEEK EVOS Straight, ,14mmx10mmx 26mm , FLAT 17 ° , Narrow Nose
00841193119878HA PEEK EVOS Straight, ,13mmx10mmx 26mm , FLAT 17 ° , Narrow Nose
00841193119861HA PEEK EVOS Straight, ,12mmx10mmx 26mm , FLAT 17 ° , Narrow Nose
00841193119854HA PEEK EVOS Straight, ,16mmx10mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119847HA PEEK EVOS Straight, ,15mmx10mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119830HA PEEK EVOS Straight, ,14mmx10mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119823HA PEEK EVOS Straight, ,13mmx10mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119816HA PEEK EVOS Straight, ,12mmx10mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119809HA PEEK EVOS Straight, ,11mmx10mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119793HA PEEK EVOS Straight, ,16mmx9mmx 26mm , FLAT 17 ° , Narrow Nose
00841193119786HA PEEK EVOS Straight, ,15mmx9mmx 26mm , FLAT 17 ° , Narrow Nose
00841193119779HA PEEK EVOS Straight, ,14mmx9mmx 26mm , FLAT 17 ° , Narrow Nose
00841193119762HA PEEK EVOS Straight, ,13mmx9mmx 26mm , FLAT 17 ° , Narrow Nose
00841193119755HA PEEK EVOS Straight, ,12mmx9mmx 26mm , FLAT 17 ° , Narrow Nose
00841193119748HA PEEK EVOS Straight, ,16mmx9mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119731HA PEEK EVOS Straight, ,15mmx9mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119724HA PEEK EVOS Straight, ,14mmx9mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119717HA PEEK EVOS Straight, ,13mmx9mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119700HA PEEK EVOS Straight, ,12mmx9mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119694HA PEEK EVOS Straight, ,11mmx9mmx 22mm , FLAT 5 ° , Narrow Nose
00841193119687HA PEEK EVOS Straight, ,16mmx10mmx 30mm , FLAT 17 ° , Narrow Nose
00841193119670HA PEEK EVOS Straight, ,15mmx10mmx 30mm , FLAT 17 ° , Narrow Nose
00841193119663HA PEEK EVOS Straight, ,14mmx10mmx 30mm , FLAT 17 ° , Narrow Nose
00841193119656HA PEEK EVOS Straight, ,13mmx10mmx 30mm , FLAT 17 ° , Narrow Nose
00841193119649HA PEEK EVOS Straight, ,16mmx9mmx 30mm , FLAT 17 ° , Wide Nose
00841193119632HA PEEK EVOS Straight, ,15mmx9mmx 30mm , FLAT 17 ° , Wide Nose
00841193119625HA PEEK EVOS Straight, ,14mmx9mmx 30mm , FLAT 17 ° , Wide Nose
00841193119618HA PEEK EVOS Straight, ,13mmx9mmx 30mm , FLAT 17 ° , Wide Nose
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.