FDA.reportPublic FDA data

NA

Primary DI
10886982300607
Brand
NA
Company
Synthes GmbH
Model
09.405.976S
Catalog number
09405976S
Device description
RADIAL HEAD W/ Ø19MM HD, Ø7.5MM STM,9(+6)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
07612334213969Direct MarkingGS10
10886982300607PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07612334213969076123342139697612334213969
1088698230060710886982300607

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
10705034717081Zero-P03.617.792036177922015-09-14
10705034717098Zero-P03.617.795036177952015-09-14
10705034717203NA03.617.907036179072015-09-14
10705034722634NA03.804.512S03804512S2019-08-10
10705034731841NA03.820.159S03820159S2019-08-10
10705034736075USS04.607.038046070382015-09-14
10705034742199Zero-P04.617.232S04617232S2015-09-14
10705034754444OPAL08.803.114088031142015-09-14
10705034754468OPAL08.803.116088031162015-09-14
10705034754529OPAL08.803.134088031342015-09-14
10705034754611OPAL08.803.214088032142015-09-14
10705034754635OPAL08.803.216088032162015-09-14
10705034754697OPAL08.803.234088032342015-09-14
10705034754741VERTEBRAL SPACER-TR08.804.037088040372015-09-14
10705034754765VERTEBRAL SPACER-TR08.804.039088040392015-09-14
10705034754826VERTEBRAL SPACER-TR08.804.047088040472015-09-14
10705034762852ACIS08.843.805088438052015-09-14
10705034762876ACIS08.843.806088438062015-09-14
10705034762890ACIS08.843.807088438072015-09-14
10705034762913ACIS08.843.808088438082015-09-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
10886982300614NASynthes GmbHKWI2020-06-08
10886982300621NASynthes GmbHKWI2020-06-08
10886982300638NASynthes GmbHKWI2020-06-08
10886982300645NASynthes GmbHKWI2020-06-08
10886982300652NASynthes GmbHKWI2020-06-08
10886982300669NASynthes GmbHKWI2020-06-08
10886982300676NASynthes GmbHKWI2020-06-08
10886982300683NASynthes GmbHKWI2020-06-08
10886982300690NASynthes GmbHKWI2020-06-08
10886982300706NASynthes GmbHKWI2020-06-08
10886982300737NASynthes GmbHKWI2020-06-08
10886982300744NASynthes GmbHKWI2020-06-08
10886982300751NASynthes GmbHKWI2020-06-08
10886982300768NASynthes GmbHKWI2020-06-08
10886982300775NASynthes GmbHKWI2020-06-08
10886982300782NASynthes GmbHKWI2020-06-08
10886982300799NASynthes GmbHKWI2020-06-08
10886982300805NASynthes GmbHKWI2020-06-08
10886982300812NASynthes GmbHKWI2020-06-08
93700386926603TEST-SALTO TALARISTORNIERKWI2019-12-23