FDA.reportPublic FDA data

E3D-C Interbody System

Primary DI
00195860031933
Brand
E3D-C Interbody System
Company
Evolution Spine LLC
Model
130-A142
Catalog number
130-A142
Device description
TRIAL 20 X 14mm 12DEG 7mm-8mm
Published
2026-02-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241846000
K260038000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241846000E3D™-C Interbody SystemEvolution Spine2024-08-12OVE
K260038000E3D™-C Interbody SystemEvolution Spine2026-02-04OVE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00195860031933PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00195860031933001958600319331958600319330195860031933

GMDN Terms#

Term, Definition table
TermDefinition
Spinal implant trialA copy of a final spinal prosthesis, graft, or other implantable spinal device (e.g., may include intervertebral disc prosthesis, spinal cage, spinal hook) used to validate the proper size of the permanent implant required by the patient, to determine its appropriate position, and/or to verify that the implant site has been cut to the proper dimensions. It can be made of metal or plastic. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(214)682-8536info@evolutionspine.com

Regulatory Flags#

DUNS number
116940934
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00195860023112EMERGE Anterior Cervical Plate System100-A068100-A0682023-08-21
00195860014042EMERGE Anterior Cervical Plate System100-A024100-A0242021-11-01
00195860014059EMERGE Anterior Cervical Plate System100-A025100-A0252021-11-01
00195860010457Skye Cervical Plate SystemCP-1007CP-10072021-06-02
00195860031803E3D-C Interbody System130-A129130-A1292026-02-20
00195860031810E3D-C Interbody System130-A130130-A1302026-02-20
00195860031827E3D-C Interbody System130-A131130-A1312026-02-20
00195860031834E3D-C Interbody System130-A132130-A1322026-02-20
00195860031841E3D-C Interbody System130-A133130-A1332026-02-20
00195860031858E3D-C Interbody System130-A134130-A1342026-02-20
00195860031865E3D-C Interbody System130-A135130-A1352026-02-20
00195860031872E3D-C Interbody System130-A136130-A1362026-02-20
00195860031889E3D-C Interbody System130-A137130-A1372026-02-20
00195860031896E3D-C Interbody System130-A138130-A1382026-02-20
00195860031902E3D-C Interbody System130-A139130-A1392026-02-20
00195860031919E3D-C Interbody System130-A140130-A1402026-02-20
00195860031926E3D-C Interbody System130-A141130-A1412026-02-20
00195860031940E3D-C Interbody System130-A143130-A1432026-02-20
00195860031957E3D-C Interbody System130-A144130-A1442026-02-20
00195860031964E3D-C Interbody System130-A145130-A1452026-02-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776404192MillenniumAvalign Technologies, Inc.LXH2026-07-24
00810135961271ToejackNVision Biomedical Technologies, Inc.LXH2026-07-24
00840314263261gSourceGSOURCE LLCLXH2026-07-24
00840314263278gSourceGSOURCE LLCLXH2026-07-24
00840314263285gSourceGSOURCE LLCLXH2026-07-24
00840314263353gSourceGSOURCE LLCLXH2026-07-24
00840314263421gSourceGSOURCE LLCLXH2026-07-24
00840314263704gSourceGSOURCE LLCLXH2026-07-24
00840314263773gSourceGSOURCE LLCLXH2026-07-24
00840314263841gSourceGSOURCE LLCLXH2026-07-24
00889024709195DRILL MEASURING SLEEVEBiomet Orthopedics, LLCLXH2026-07-24
07640221373694SCALASpineArt SALXH2026-07-24
07640221373700SCALASpineArt SALXH2026-07-24
10886982362179NASynthes GmbHLXH2026-07-24
B382SD9141071020Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071030Surgical DirectSurgical Direct, Inc.LXH2026-07-24
B382SD9141071040Surgical DirectSurgical Direct, Inc.LXH2026-07-24
00840097534206Velora Acetabular System InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534923Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00840097534930Veritas InstrumentationRestor3d, Inc.LXH2026-07-23
00818720013398SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013404SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013411SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013428SuperCable® ISO-Elastic™ Cerclage SystemKinamed, Inc.LXH2026-07-22
00818720013435KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00818720013442KineMatch® PFR SystemKinamed, Inc.LXH2026-07-22
00850075111121NativeINS ORTHO INC.LXH2026-07-22
10810128463116StayPort™ shoulder reusable obturator 5 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463123StayPort™ shoulder reusable obturator 5 mm x 90 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21
10810128463130StayPort™ shoulder reusable obturator 7 mm x 70 mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONLXH2026-07-21