FDA.reportPublic FDA data

EVOS Lumbar Interbody System

Primary DI
00841193119786
Brand
EVOS Lumbar Interbody System
Company
Cutting Edge Spine, LLC
Model
4915-015
Catalog number
4915-015
Device description
HA PEEK EVOS Straight, ,15mmx9mmx 26mm , FLAT 17 ° , Narrow Nose
Published
2016-01-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral fusion device with bone graft, lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150321000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150321000EVOS Lumbar Interbody SystemCutting Edge Spine, LLC2015-07-13MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00841193119786PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00841193119786008411931197868411931197860841193119786

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal fusion cage, sterileA sterile device intended to help fuse segments of the spine to treat anatomical abnormalities of the vertebrae, typically due to degenerative intervertebral disks [i.e., degenerative disc disease (DDD)]. The device is typically designed as a small, hollow and/or porous, threaded or fenestrated cylinder (or other geometric form) and is made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that is implanted between the bones or bone grafts of the spine, to provide mechanical stability and sufficient space for bone fusion to occur. Disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length26Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store at room temperature

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
069472647
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00841193127996T-FIX™3Dsi Joint Fusion SystemCES-6432026-03-24
00841193127521EVOL®ha-Hyper C Cervical Interbody System6012-0507A6012-0507A2026-03-11
00841193127538EVOL®ha-Hyper C Cervical Interbody System6012-0607A6012-0607A2026-03-11
00841193127545EVOL®ha-Hyper C Cervical Interbody System6012-0707A6012-0707A2026-03-11
00841193127552EVOL®ha-Hyper C Cervical Interbody System6012-0807A6012-0807A2026-03-11
00841193127569EVOL®ha-Hyper C Cervical Interbody System6012-0907A6012-0907A2026-03-11
00841193127576EVOL®ha-Hyper C Cervical Interbody System6012-1007A6012-1007A2026-03-11
00841193127583EVOL®ha-Hyper C Cervical Interbody System6012-1107A6012-1107A2026-03-11
00841193127590EVOL®ha-Hyper C Cervical Interbody System6012-1207A6012-1207A2026-03-11
00841193127606EVOL®ha-Hyper C Cervical Interbody System6013-0512A6013-0512A2026-03-11
00841193127613EVOL®ha-Hyper C Cervical Interbody System6013-0612A6013-0612A2026-03-11
00841193127620EVOL®ha-Hyper C Cervical Interbody System6013-0712A6013-0712A2026-03-11
00841193127637EVOL®ha-Hyper C Cervical Interbody System6013-0812A6013-0712A2026-03-11
00841193127644EVOL®ha-Hyper C Cervical Interbody System6013-0912A6013-0912A2026-03-11
00841193127651EVOL®ha-Hyper C Cervical Interbody System6013-1012A6013-1012A2026-03-11
00841193127668EVOL®ha-Hyper C Cervical Interbody System6013-1112A6013-1112A2026-03-11
00841193127675EVOL®ha-Hyper C Cervical Interbody System6013-1212A6013-1212A2026-03-11
00841193101934EVOS Lumbar Interbody System4014-0164014-0162015-10-30
00841193104836EVOS Lumbar Interbody System4067-0104067-0102015-10-30
00841193105635EVOS Lumbar Interbody System4004-0144004-0142016-01-12

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Primary DI, Brand, Company table
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B707125355730700DUALX DUAL PORTAL DISPOSABLE KIT-70MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
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B707125355730900DUALX DUAL PORTAL DISPOSABLE KIT-90MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731000DUALX DUAL PORTAL DISPOSABLE KIT-100MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731100DUALX DUAL PORTAL DISPOSABLE KIT-110MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
B707125355731200DUALX DUAL PORTAL DISPOSABLE KIT-120MM (USA)AMPLIFY SURGICAL, INC.MAX2026-09-04
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