FDA.reportPublic FDA data

Mbrace System

Primary DI
07630542713255
Brand
Mbrace System
Company
Medacta International SA
Model
01.23.0017
Device description
Mbrace Cable
Published
2024-05-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
JDQCerclage, Fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDQCerclage, FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K232733000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232733000Mbrace CableMedacta International S.A.2024-05-03JDQ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630542713255PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542713255076305427132557630542713255

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone cerclage wireAn implantable thin metallic cord intended to be tightened with a knot to form a loop or ring around a fractured orthopaedic bone and/or stabilize an implant (typically a fixation plate) for treatment. It is not rigid (i.e., not a pin/K-wire) and not intended to be used in spinal bones. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630542788314AMIStem-P13.000092026-06-08
07630542788321AMIStem-P13.000102026-06-08
07630542788338AMIStem-P13.000112026-06-08
07630542788345AMIStem-P13.000122026-06-08
07630542788352AMIStem-P13.000132026-06-08
07630542788369AMIStem-P13.000142026-06-08
07630542788376AMIStem-P13.000152026-06-08
07630971243637AMIStem-P Short Neck01.18.4592020-01-29
07630971243644AMIStem-P Short Neck01.18.4602020-01-29
07630971243651AMIStem-P Short Neck01.18.4612020-01-29
07630971243668AMIStem-P Short Neck01.18.4622020-01-29
07630971243675AMIStem-P Short Neck01.18.4632020-01-29
07630971243682AMIStem-P Short Neck01.18.4642020-01-29
07630971243699AMIStem-P Short Neck01.18.4652020-01-29
07630971243705AMIStem-P Short Neck01.18.4662020-01-29
07630971243712AMIStem-P Short Neck01.18.4672020-01-29
07630971243729AMIStem-P Short Neck01.18.4682020-01-29
07630971243736AMIStem-P Short Neck01.18.4692020-01-29
07630971243743AMIStem-P Short Neck01.18.4702020-01-29
07630971243750AMIStem-P Short Neck01.18.4712020-01-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07899258607887Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258607900Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654850Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654867Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654874Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654881Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654898Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654904Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654911Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654928Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654935Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654942Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654959Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654966Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654973Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654980Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258654997Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258655017Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258655024Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258655338Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258657714Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258657721Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258657738Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258657745Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258657752Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258657776Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258657790Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-17
07899258601151Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607818Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16
07899258607825Versalock Periprosthetic Femur Plates System-GMReisGM DOS REIS INDUSTRIA E COMERCIO LTDAJDQ2024-01-16