EVOL Lumbar Interbody System CLB04013

GUDID 00841193101095

11X13mm,X 10mm X 23 mm Lordotic LIF Cage

Cutting Edge Spine, LLC

Polymeric spinal interbody fusion cage

Primary Device ID	00841193101095
NIH Device Record Key	d73ea892-87cb-4314-93a1-f0d3bc4f794e
Commercial Distribution Status	In Commercial Distribution
Brand Name	EVOL Lumbar Interbody System
Version Model Number	CLB04013
Catalog Number	CLB04013
Company DUNS	069472647
Company Name	Cutting Edge Spine, LLC
Device Count	1
DM Exempt	true
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	true
Lot Batch	true
Serial Number	false
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Customer Support Contacts

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

Device Dimensions

Length

23 Millimeter

Operating and Storage Conditions

Special Storage Condition, Specify

Between 0 and 0 *Store at room temperature

Device Identifiers

Device Issuing Agency	Device ID
GS1	00841193101095 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

Premarket Notification: K102957

FDA Product Code

MAX	Intervertebral fusion device with bone graft, lumbar

Sterilization

Steralize Prior To Use	true
Device Is Sterile	false

[00841193101095]

Moist Heat or Steam Sterilization

Device Entry Metadata

Public Version Status	Update
Device Record Status	Published
Public Version Number	4
Public Version Date	2020-02-24
Device Publish Date	2015-10-30

On-Brand Devices [EVOL Lumbar Interbody System]

00841193103082	EVOL Straight Lateral Inserter
00841193103075	EVOL Straight PLIF Inserter
00841193120454	7X9mm,X 10mm X 23 mm Lordotic LIF Cage
00841193120447	17 X 20 X 55 mm RLIF Cage
00841193120430	16 X 20 X 55 mm RLIF Cage
00841193120423	15 X 20 X 55 mm RLIF Cage
00841193120416	14 X 20 X 55 mm RLIF Cage
00841193120409	13 X 20 X 55 mm RLIF Cage
00841193120393	7 X 20 X 55 mm RLIF Cage
00841193120386	17 X 20 X 40 mm RLIF Cage
00841193120379	16 X 20 X 40 mm RLIF Cage
00841193120362	15 X 20 X 40 mm RLIF Cage
00841193120355	14 X 20 X 40 mm RLIF Cage
00841193120348	13 X 20 X 40 mm RLIF Cage
00841193120331	7 X 20 X 40 mm RLIF Cage
00841193120324	17 X 20 X 45 mm RLIF Cage
00841193120317	16 X 20 X 45 mm RLIF Cage
00841193120300	15 X 20 X 45 mm RLIF Cage
00841193120294	14 X 20 X 45 mm RLIF Cage
00841193120287	13 X 20 X 45 mm RLIF Cage
00841193120270	7 X 20 X 45 mm RLIF Cage
00841193120263	7 X 20 X 50 mm RLIF Cage
00841193120256	17 X 20 X 50 mm RLIF Cage
00841193120249	16 X 20 X 50 mm RLIF Cage
00841193120232	15 X 20 X 50 mm RLIF Cage
00841193120225	14 X 20 X 50 mm RLIF Cage
00841193120218	13 X 20 X 50 mm RLIF Cage
00841193119953	12 X 20 X 40 mm RLIF Cage
00841193119946	11 X 20 X 40 mm RLIF Cage
00841193119939	10 X 20 X 40 mm RLIF Cage
00841193119922	9 X 20 X 40 mm RLIF Cage
00841193119915	8 X 20 X 40 mm RLIF Cage
00841193103037	16mm X 12mm X 28mm Parallel CLIF Cage
00841193103020	15mm X 12mm X 28mm Parallel CLIF Cage
00841193103013	16mm X 12mm X 32mm Parallel CLIF Cage
00841193103006	15mm X 12mm X 32mm Parallel CLIF Cage
00841193102993	14mm X 12mm X 32mm Parallel CLIF Cage
00841193102986	13mm X 12mm X 32mm Parallel CLIF Cage
00841193102979	12mm X 12mm X 32mm Parallel CLIF Cage
00841193102962	11mm X 12mm X 32mm Parallel CLIF Cage
00841193102955	10mm X 12mm X 32mm Parallel CLIF Cage
00841193102948	9mm X 12mm X 32mm Parallel CLIF Cage
00841193102931	8mm X 12mm X 32mm Parallel CLIF Cage
00841193102924	14mm X 12mm X 28mm Parallel CLIF Cage
00841193102917	13mm X 12mm X 28mm Parallel CLIF Cage
00841193102900	12mm X 12mm X 28mm Parallel CLIF Cage
00841193102894	11mm X 12mm X 28mm Parallel CLIF Cage
00841193102887	10mm X 12mm X 28mm Parallel CLIF Cage
00841193102870	9mm X 12mm X 28mm Parallel CLIF Cage
00841193102863	8mm X 12mm X 28mm Parallel CLIF Cage