FDA.reportPublic FDA data

trial implant

Primary DI
04250337111153
Brand
trial implant
Company
Joimax GmbH
Model
ELO640010T
Catalog number
ELO640010T
Device description
Trial Implant Cages 10
Published
2022-12-30
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
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
K151143000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K151143000EndoLIF On-CageJoimax GmbH2015-07-09MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04250337111153PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04250337111153042503371111534250337111153

GMDN Terms#

Term, Definition table
TermDefinition
Internal spinal fixation procedure kit, reusableA collection of various orthopaedic manual surgical instruments (e.g., screwdriver, trial rod, adaptor, mallet, guide tube, chisel, rasp, awl, burr, tap, drill) intended to be used to perform a bone-screw internal spinal fixation and/or spinal fusion cage implantation procedure (including stereotactic procedures); implanted devices are not included. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+497212551407010info@joimax.com

Regulatory Flags#

DUNS number
344267187
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04250337117933Punching Adapter for Working TubeWTPA7695172026-10-22
04250337119180Guiding Tube, eccentrically cannulated, redGRD1964402026-10-22
04250337119197Guiding Tube, eccentrically cannulated, purpleGRD1774402026-10-22
04250337119203Working Tube with Handle, oblique 45°WTS1785032026-10-22
04250337119562Guiding Tube, conicalGTC1675962026-10-22
04250337119579Guiding rod , conicalGRD226320A.2026-10-22
04250337119586Guiding rod , conicalGRD226320B.2026-10-22
04250337119593Working Tube with crown half teeth tipWTS1780932026-10-22
04250337119647Working Tube with handle, Standard lipWTS2446592026-10-22
04250337119678Guiding rod, conical, longitudinal slantedGRD2042782026-10-22
04250337119791Working Tube with long lipWTS176050.2026-10-22
04250337120834Working tube, long lipWTDS1785752026-10-22
04250337121862Working Tube with Handle, Standard LipWTS1112002026-10-22
04250337121909Working Tube with Handle, Standard LipWTS111300T2026-10-22
04250337121916Working Tube with Handle, oblique 35°WTS1112032026-10-22
04250337121923Working Tube with Handle, oblique 35°WTS111303T2026-10-22
04250337121930Working Tube with Handle, long lipWTS1413022026-10-22
04250337122029Guiding Rod, conicalGRC1800102026-10-22
04250337122036Guiding Rod, conical, greenGRC2000392026-10-22
04250337121015Combo Optic AdapterADAPTC12026-10-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840606176347LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606184847LucentSPINAL ELEMENTS, INC.MAX2026-10-22
00840606197106LucentSPINAL ELEMENTS, INC.MAX2026-10-22
B648C29510000Savant Lumbar Interbody Fusion SystemCURITEVA, INC.MAX2026-10-19
M719GLL11403DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11503DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
M719GLL11603DP Lumbar Interbody SystemGenesys Orthopedics Systems LLCMAX2026-10-19
00810161900381EARP, 14X25X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900398EARP, 14X25X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900404EARP, 14X25X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900411EARP, 14X25X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900428EARP, 14X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900435EARP, 14X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900442EARP, 14X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900459EARP, 14X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900466EARP, 14X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900473EARP, 14X35X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900480EARP, 14X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900497EARP, 14X35X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900503EARP, 14X40X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900510EARP, 14X40X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900527EARP, 14X40X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900534EARP, 18X30X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900541EARP, 18X30X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900558EARP, 18X30X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900565EARP, 18X30X12 12°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900572EARP, 18X35X08 0°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900589EARP, 18X35X10 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900596EARP, 18X35X12 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16
00810161900602EARP, 18X35X14 6°RETROPSOAS TECHNOLOGIES, LLCMAX2026-10-16