FDA.reportPublic FDA data

RHEAD

Primary DI
00886385022680
Brand
RHEAD
Company
Stryker Trauma SA
Model
310-0001
Catalog number
310-0001
Device description
Lateral Assembly, Radial Stem Implant, Size 2
Published
2015-09-24
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

Product Codes#

Code, Name table
CodeName
JDBPROSTHESIS, ELBOW, SEMI-CONSTRAINED, CEMENTED
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDBProsthesis, Elbow, Semi-Constrained, CementedOrthopedic2
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886385022680PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385022680008863850226808863850226800886385022680

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

Regulatory Flags#

DUNS number
481999654
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
07613327667738NASIT0006000SIT00060002025-03-28
07613327084191STEINMANN3593-1-0903593-1-0902025-01-09
07613327614633PANGEA5420045420042024-12-01
07613327624786PANGEA542110S542110S2024-12-01
07613327624809PANGEA5421125421122024-12-01
07613327624816PANGEA5421375421372024-12-01
07613327624830PANGEA5421855421852024-12-01
07613327624847PANGEA5421385421382024-12-01
07613327624861PANGEA5421185421182024-12-01
07613327624878PANGEA5421365421362024-12-01
07613327624885PANGEA5421195421192024-12-01
07613327624908PANGEA5421325421322024-12-01
07613327624915PANGEA542130S542130S2024-12-01
07613327624939PANGEA5421395421392024-12-01
07613327624977PANGEA5421725421722024-12-01
07613327624984PANGEA5421545421542024-12-01
07613327624991PANGEA5421205421202024-12-01
07613327625011PANGEA542132S542132S2024-12-01
07613327625028PANGEA5421135421132024-12-01
07613327625035PANGEA5421865421862024-12-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00841506148953AlignSKELETAL DYNAMICS L.L.C.KWI2025-12-01
00841506148960AlignSKELETAL DYNAMICS L.L.C.KWI2025-12-01
00850005618034BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618041BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618058BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618065BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618072BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618089BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618249BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618256BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618263BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618287BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618294BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618461BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618478BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618485BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618492BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618508BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618522BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618539 BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618546BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618553BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618560BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618577BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618584BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618591BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618607BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618614BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618621BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02
00850005618638BioPoly® Radial Head ImplantBiopoly, LLCKWI2025-01-02