FDA.reportPublic FDA data

NA

Primary DI
07612334213884
Brand
NA
Company
Synthes GmbH
Model
09.405.950S
Catalog number
09405950S
Device description
RADIAL HEAD W/ Ø19MM HD, Ø5.5MM STM,9(+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
OTC
false
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
07612334213884Direct MarkingGS10
10886982300522PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612334213884076123342138847612334213884
1088698230052210886982300522

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

Contacts#

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

Regulatory Flags#

DUNS number
486711679
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810112596793TriLEAP04.900.151049001512026-02-19
00810112597202TriLEAP04.913.035049130352026-02-19
00810112597219TriLEAP04.913.040049130402026-02-19
00810112597226TriLEAP04.913.045049130452026-02-19
00810112597233TriLEAP04.913.050049130502026-02-19
00810112597240TriLEAP04.913.055049130552026-02-19
00810112597257TriLEAP04.913.060049130602026-02-19
00810112597264TriLEAP04.913.065049130652026-02-19
00810112597271TriLEAP04.914.035049140352026-02-19
00810112597288TriLEAP04.914.040049140402026-02-19
00810112597295TriLEAP04.914.050049140502026-02-19
00810112597301TriLEAP04.914.045049140452026-02-19
00810112597318TriLEAP04.914.055049140552026-02-19
00810112597325TriLEAP04.914.060049140602026-02-19
00810112597332TriLEAP04.914.065049140652026-02-19
00810112598933TriLEAP04.900.118049001182026-02-19
00810112598940TriLEAP04.900.119049001192026-02-19
00810112598957TriLEAP04.900.120049001202026-02-19
00810112598964TriLEAP04.900.121049001212026-02-19
00810112598971TriLEAP04.900.122049001222026-02-19

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