FDA.reportPublic FDA data

NA

Primary DI
10886982300737
Brand
NA
Company
Synthes GmbH
Model
09.405.560S
Catalog number
09405560S
Device description
RADIAL HEAD W/ Ø25MM HD, Ø6.5MM STM,11(+0)MM HD HT,STER
Published
2020-06-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
K183618000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183618000Revolution Radial HeadIgnite Orthopedics, Inc.2019-05-17KWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07612334213792Direct MarkingGS10
10886982300737PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612334213792076123342137927612334213792
1088698230073710886982300737

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.

Contacts#

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

Regulatory Flags#

DUNS number
486711679
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112599275TriLEAP04.900.251049002512025-03-20
00810112599169TriLEAP04.900.240049002402025-03-18
00810112599763TriLEAP03.900.407039004072025-03-18
00810112599176TriLEAP04.900.241049002412025-03-17
00810112599183TriLEAP04.900.242049002422025-03-17
00810112599190TriLEAP04.900.243049002432025-03-17
00810112599206TriLEAP04.900.244049002442025-03-17
00810112599213TriLEAP04.900.245049002452025-03-17
00810112599220TriLEAP04.900.246049002462025-03-17
00810112599237TriLEAP04.900.247049002472025-03-17
00810112599244TriLEAP04.900.248049002482025-03-17
00810112599251TriLEAP04.900.249049002492025-03-17
00810112599268TriLEAP04.900.250049002502025-03-17
00810112592467TriLeap Lower Etremity Anatomic Plating System60.900.307609003072024-02-23
00810112592528TriLeap Lower Extremity Anatomic Plating03.900.311039003112024-02-23
00810112592566TriLeap Lower Etremity Anatomic Plating System03.900.332039003322024-02-23
00810112597035TriLeap Lower Extremity Plating System04.900.057049000572024-02-21
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894827495AVENGERMedartis AGKWI2026-10-21
07630894827501AVENGERMedartis AGKWI2026-10-21
07630894827518AVENGERMedartis AGKWI2026-10-21
07630894827525AVENGERMedartis AGKWI2026-10-21
07630894827532AVENGERMedartis AGKWI2026-10-21
07630894827549AVENGERMedartis AGKWI2026-10-21
07630894827556AVENGERMedartis AGKWI2026-10-21
07630894827563AVENGERMedartis AGKWI2026-10-21
07630894827570AVENGERMedartis AGKWI2026-10-21
07630894827587AVENGERMedartis AGKWI2026-10-21
07630894827594AVENGERMedartis AGKWI2026-10-21
07630894827600AVENGERMedartis AGKWI2026-10-21
07630894827617AVENGERMedartis AGKWI2026-10-21
07630894827624AVENGERMedartis AGKWI2026-10-21
07630894827631AVENGERMedartis AGKWI2026-10-21
07630894827648AVENGERMedartis AGKWI2026-10-21
07630894827655AVENGERMedartis AGKWI2026-10-21
07630894827662AVENGERMedartis AGKWI2026-10-21
07630894827679AVENGERMedartis AGKWI2026-10-21
07630894827686AVENGERMedartis AGKWI2026-10-21
07630894827693AVENGERMedartis AGKWI2026-10-21
07630894827709AVENGERMedartis AGKWI2026-10-21
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