FDA.reportPublic FDA data

CONDUIT ATP Cobb 22mm 24° Right

Primary DI
09421028118491
Brand
CONDUIT ATP Cobb 22mm 24° Right
Company
ENZTEC LIMITED
Model
287361244
Catalog number
287361244
Device description
Intended to be used for the insertion of spinal implants into the spinal space during total artificial disc replacement surgery.
Published
2023-12-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09421028118491PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09421028118491094210281184919421028118491

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
592616445
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09421038412237KA Femoral Alignment Guide293-777293-7772026-06-24
09421038412244KA Femoral Alignment Guide - Medial Paddle293-778293-7782026-06-24
09421038412251KA Femoral Alignment Guide - Lateral Paddle293-779293-7792026-06-24
09421038412268KA Femoral Alignment Guide - Fan293-780293-7802026-06-24
09421038412275KA Femoral Alignment Guide – IM Guide293-781293-7812026-06-24
09421038412282KA Femoral Alignment Guide – Pin Guide Connector293-782293-7822026-06-24
09421038413159Reamer, Acetabular, 36mm Full5900-RF365900-RF362026-04-16
09421038413166Reamer, Acetabular, 37mm Full5900-RF375900-RF372026-04-16
09421038413173Reamer, Acetabular, 38mm Full5900-RF385900-RF382026-04-16
09421038413180Reamer, Acetabular, 39mm Full5900-RF395900-RF392026-04-16
09421038413197Reamer, Acetabular, 40mm Full5900-RF405900-RF402026-04-16
09421038413203Reamer, Acetabular, 41mm Full5900-RF415900-RF412026-04-16
09421038413210Reamer, Acetabular, 42mm Full5900-RF425900-RF422026-04-16
09421038413227Reamer, Acetabular, 43mm Full5900-RF435900-RF432026-04-16
09421038413234Reamer, Acetabular, 44mm Full5900-RF445900-RF442026-04-16
09421038413241Reamer, Acetabular, 45mm Full5900-RF455900-RF452026-04-16
09421038413258Reamer, Acetabular, 46mm Full5900-RF465900-RF462026-04-16
09421038413265Reamer, Acetabular, 47mm Full5900-RF475900-RF472026-04-16
09421038413272Reamer, Acetabular, 48mm Full5900-RF485900-RF482026-04-16
09421038413289Reamer, Acetabular, 49mm Full5900-RF495900-RF492026-04-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08800043913136N/ATDM Co., Ltd.MAX2026-06-10
08800043913143N/ATDM Co., Ltd.MAX2026-06-10
08800043913150N/ATDM Co., Ltd.MAX2026-06-10
08800043913167N/ATDM Co., Ltd.MAX2026-06-10
08800043913174N/ATDM Co., Ltd.MAX2026-06-10
08800043913181N/ATDM Co., Ltd.MAX2026-06-10
08800043913198N/ATDM Co., Ltd.MAX2026-06-10
08800043913204N/ATDM Co., Ltd.MAX2026-06-10
08800043913211N/ATDM Co., Ltd.MAX2026-06-10
08800043917288N/ATDM Co., Ltd.MAX2026-06-10
08800043917295N/ATDM Co., Ltd.MAX2026-06-10
08800043917301N/ATDM Co., Ltd.MAX2026-06-10
08800043917318N/ATDM Co., Ltd.MAX2026-06-10
08800043917325N/ATDM Co., Ltd.MAX2026-06-10
08800043917332N/ATDM Co., Ltd.MAX2026-06-10
08800043917349N/ATDM Co., Ltd.MAX2026-06-10
08800043967177N/ATDM Co., Ltd.MAX2026-06-10
08800043967184N/ATDM Co., Ltd.MAX2026-06-10
08800043967191N/ATDM Co., Ltd.MAX2026-06-10
08800043967207N/ATDM Co., Ltd.MAX2026-06-10
08800043967214N/ATDM Co., Ltd.MAX2026-06-10
08800043967221N/ATDM Co., Ltd.MAX2026-06-10
08800043967238N/ATDM Co., Ltd.MAX2026-06-10
08800043967245N/ATDM Co., Ltd.MAX2026-06-10
08800043967252N/ATDM Co., Ltd.MAX2026-06-10
08800043967269N/ATDM Co., Ltd.MAX2026-06-10