FDA.reportPublic FDA data

T2

Primary DI
07613252132493
Brand
T2
Company
Stryker GmbH
Model
1851-0824S
Catalog number
1851-0824S
Device description
Femoral Nail, RIGHT
Published
2015-09-24
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

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K101438000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K101438000T2 GREATER TROCHANTER NAILHowmedica Osteonics Corp.2010-06-17HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613252132493PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613252132493076132521324937613252132493

GMDN Terms#

Term, Definition table
TermDefinition
Femur nail, sterileA sterile rod made of metal or other material which, when inserted into the intramedullary canal of the femur, acts to immobilize by holding the ends of a fractured bone in position to promote healing. The device may also be used to support the bone in the presence of a pathological condition, or for knee arthrodesis. The device may be a locked or unlocked model, and possess components to assist fixation of more proximal or distal conditions. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length240Millimeter

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327649109T2, PANGEA5431405431402025-09-25
07613327649130T2, PANGEA5431705431702025-09-25
07613327649253T2, PANGEA6497-1-0606497-1-0602025-09-25
07613327649260T2, PANGEA6497-1-0706497-1-0702025-09-25
07613327649277T2, PANGEA6497-1-070S6497-1-070S2025-09-25
07613327649284T2, PANGEA6497-1-060S6497-1-060S2025-09-25
07613327649291T2, PANGEA6497-1-0806497-1-0802025-09-25
07613327649307T2, PANGEA6497-1-0906497-1-0902025-09-25
07613327649314T2, PANGEA6497-1-080S6497-1-080S2025-09-25
07613327649321T2, PANGEA6497-1-090S6497-1-090S2025-09-25
07613327649338T2, PANGEA6497-1-1006497-1-1002025-09-25
07613327649345T2, PANGEA6497-1-1106497-1-1102025-09-25
07613327649352T2, PANGEA6497-1-100S6497-1-100S2025-09-25
07613327649369T2, PANGEA6497-1-110S6497-1-110S2025-09-25
07613327649376T2, PANGEA6497-1-1306497-1-1302025-09-25
07613327649383T2, PANGEA6497-1-130S6497-1-130S2025-09-25
07613327649390T2, PANGEA6497-1-120S6497-1-120S2025-09-25
07613327649406T2, PANGEA6497-1-1206497-1-1202025-09-25
07613327649413T2, PANGEA6497-1-1406497-1-1402025-09-25
07613327649420T2, PANGEA6497-2-0706497-2-0702025-09-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867417229Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417236Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417250Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417274Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417281Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417298Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417304Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417311Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417328Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417335Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417342Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417359Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417366Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417373Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417380Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417397Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417403Arthrex®ARTHREX, INC.HSB2026-07-22
00888867417410Arthrex®ARTHREX, INC.HSB2026-07-22
00193982660086AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660109AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660123AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660147AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660161AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660185AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660208AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660222AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660246AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660260AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660284AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10
00193982660307AUTOBAHNGLOBUS MEDICAL, INC.HSB2026-06-10