FDA.reportPublic FDA data

MATRIX

Primary DI
03596010012296
Brand
MATRIX
Company
Smith & Nephew, Inc.
Model
MT2200
Catalog number
MT2200
Device description
MATRIX CEMENTED CUP POSITIONER
Published
2015-08-29
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDGProsthesis, hip, femoral component, cemented, metal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDGProsthesis, Hip, Femoral Component, Cemented, MetalOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123598000SMITH & NEPHEW, INC. HIP SYSTEM INSTRUMENTATIONSmith & Nephew, Inc.2013-06-28JDI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03596010012296PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03596010012296035960100122963596010012296

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments. It may be used for the following applications: 1) to hold/align/fix bone preparation instruments, prosthesis, or prosthesis component; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)821-5700gudid@smith-nephew.com

Regulatory Flags#

DUNS number
045483575
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00885556165560NA76515310765153102026-07-16
00885556923023NA76547001765470012026-07-16
00885556925089NA74034445740344452026-07-14
00885556925379CORIOGRAPHROB20032ROB200322026-07-08
00885556925386CORIOGRAPHROB20031ROB200312026-07-08
00885556904879EVOS70887105708871052026-06-25
00885556904923EVOS70897130708971302026-06-25
00885556906163EVOS70879090708790902026-06-25
00885556906170EVOS70879095708790952026-06-25
00885556906187EVOS70879100708791002026-06-25
00885556906194EVOS70879105708791052026-06-25
00885556906200EVOS70879110708791102026-06-25
00885556906217EVOS70879115708791152026-06-25
00885556906224EVOS70879120708791202026-06-25
00885556906231EVOS70879125708791252026-06-25
00885556906248EVOS70879130708791302026-06-25
00885556906255EVOS70879135708791352026-06-25
00885556906262EVOS70879140708791402026-06-25
00885556906279EVOS70879145708791452026-06-25
00885556906286EVOS70879150708791502026-06-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07613327383386ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383430ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383454ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383461ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383485ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383515ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383522ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383553ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383591ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383614ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383621ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383676ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383706ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383713ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383737ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383744ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383751ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383805ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383812ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383836ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383843ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383904ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327383911ExeterHowmedica Osteonics Corp.JDG2022-11-30
07613327123852V40Howmedica Osteonics Corp.JDG2018-06-13
07613327123739EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123746EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123753EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123777EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123791EXETERHowmedica Osteonics Corp.JDG2018-05-03
07613327123845EXETERHowmedica Osteonics Corp.JDG2018-05-03