FDA.reportPublic FDA data

NA

Primary DI
10886982080257
Brand
NA
Company
Synthes GmbH
Model
03.402.717
Catalog number
03402717
Device description
7MM BROACH/STRAIGHT TIP FOR RADIAL HEAD PROSTHESIS
Published
2015-09-14
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
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K112030000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K112030000SYNTHES RADIAL HEAD PROSTHESIS SYSTEMSynthes USA, LLC2012-06-19KWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07611819509214Direct MarkingGS10
10886982080257PrimaryGS10
H679034027170SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07611819509214076118195092147611819509214
1088698208025710886982080257

GMDN Terms#

Term, Definition table
TermDefinition
Elbow radius prosthesisA sterile implantable device designed to replace the proximal radius typically as treatment for severe radial head fracture or degenerative disease (arthritis). The device includes a radial head or radial head with stem and is made of metal [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] or metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10886982312327NA68.134.011681340112026-10-16
10886982346704VOLT68.134.111681341112026-10-16
10886982346735VOLT68.134.200681342002026-10-16
10886982363282NA68.045.017680450172026-10-16
10886982363299NA68.045.018680450182026-10-16
10886982363305NA68.045.019680450192026-10-16
10886982363312NA68.045.020680450202026-10-16
10705034753690ChronOS07.801.100.99S0780110099S2015-09-14
10705034753706ChronOS07.801.101.99S0780110199S2015-09-14
10705034753713ChronOS07.801.110.99S0780111099S2015-09-14
10705034753720ChronOS07.801.111.99S0780111199S2015-09-14
10705034753737ChronOS07.801.200.99S0780120099S2015-09-14
10705034799933ChronOS710.002.99S71000299S2015-09-14
10705034799940ChronOS710.014.99S71001499S2015-09-14
10705034799957ChronOS710.019.99S71001999S2015-09-14
10705034799964ChronOS710.021.99S71002199S2015-09-14
10705034799971ChronOS710.025.99S71002599S2015-09-14
10705034799988ChronOS710.026.99S71002699S2015-09-14
10705034799995ChronOS710.027.99S71002799S2015-09-14
10705034800004ChronOS710.038.99S71003899S2015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885556830543PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00885556830550PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00885556830567PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00885556830574PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00888867570764Arthrex®ARTHREX, INC.KWI2026-09-21
00888867570771Arthrex®ARTHREX, INC.KWI2026-09-21
00888867568044Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568051Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568068Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568075Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568082Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568099Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568129Arthrex®ARTHREX, INC.KWI2026-09-17
00885556827307Katalyst Bipolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
00885556827314Katalyst Bipolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
00885556827338Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
00885556827345Katalyst Biopolar Radial Head SystemSmith & Nephew, Inc.KWI2022-12-21
10886982300713NASynthes GmbHKWI2020-06-17
10886982300720NASynthes GmbHKWI2020-06-17
10886982300522NASynthes GmbHKWI2020-06-08
10886982300539NASynthes GmbHKWI2020-06-08
10886982300546NASynthes GmbHKWI2020-06-08
10886982300553NASynthes GmbHKWI2020-06-08
10886982300560NASynthes GmbHKWI2020-06-08
10886982300577NASynthes GmbHKWI2020-06-08
10886982300584NASynthes GmbHKWI2020-06-08
10886982300591NASynthes GmbHKWI2020-06-08
10886982300607NASynthes GmbHKWI2020-06-08
10886982300614NASynthes GmbHKWI2020-06-08
10886982300621NASynthes GmbHKWI2020-06-08