FDA.reportPublic FDA data

T2

Primary DI
04546540515445
Brand
T2
Company
Stryker GmbH
Model
1832-0009S
Catalog number
1832-0009S
Device description
Washer, small
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
HSBROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
HTNWASHER, BOLT NUT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSBRod, Fixation, Intramedullary And AccessoriesOrthopedic2
HTNWasher, Bolt NutOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K011529000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K011529000T2 HUMERAL NAIL SYSTEMHowmedica Osteonics Corp.2001-06-12HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540515445PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540515445045465405154454546540515445

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone washerA flat thin ring or plate typically used with a nut and bolt/screw to improve tightness in an orthopaedic fixation assembly. The washer may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length15Millimeter
Width8Millimeter

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
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27
00886385019826SR PIP17-13232017-06-27
00886385019833SR PIP17-13242017-06-27
00886385019840SR PIP17-13252017-06-27
00886385019857SR PIP17-13262017-06-27
00886385019864SR PIP17-13272017-06-27
00886385019871SR PIP17-13282017-06-27
00886385019888SR PIP17-13292017-06-27
00886385019895SR PIP17-13302017-06-27
00886385019901SR PIP17-13312017-06-27
00886385019918SR PIP17-13322017-06-27
00886385019925SR PIP17-13332017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07901125602533Expert KnotlessGM DOS REIS INDUSTRIA E COMERCIO LTDAHTN2026-05-28
07613327075830ASNISStryker GmbHHTN2015-11-11
07613327076189ASNISStryker GmbHHTN2015-11-11
07613327076301ASNISStryker GmbHHTN2015-11-11
07613327076554ASNISStryker GmbHHTN2015-11-11
07613327076721ASNISStryker GmbHHTN2015-11-11
07613327076929ASNISStryker GmbHHTN2015-11-11
07613327077049ASNISStryker GmbHHTN2015-11-11
07613327077308ASNISStryker GmbHHTN2015-11-11
07613327077315ASNISStryker GmbHHTN2015-11-11
07613327077346ASNISStryker GmbHHTN2015-11-11
07613327073737VARIAXStryker GmbHHTN2015-09-30
07613327073768VARIAXStryker GmbHHTN2015-09-30
07613327073799VARIAXStryker GmbHHTN2015-09-30
07613327073812VARIAXStryker GmbHHTN2015-09-30
07613327073843VARIAXStryker GmbHHTN2015-09-30
07613327073881VARIAXStryker GmbHHTN2015-09-30
07613327073904VARIAXStryker GmbHHTN2015-09-30
07613327073935VARIAXStryker GmbHHTN2015-09-30
07613327073973VARIAXStryker GmbHHTN2015-09-30
07613327073997VARIAXStryker GmbHHTN2015-09-30
07613327074031VARIAXStryker GmbHHTN2015-09-30
07613327074079VARIAXStryker GmbHHTN2015-09-30
07613327074093VARIAXStryker GmbHHTN2015-09-30
07613327074130VARIAXStryker GmbHHTN2015-09-30
07613327074147VARIAXStryker GmbHHTN2015-09-30
07613327074178VARIAXStryker GmbHHTN2015-09-30
07613327074208VARIAXStryker GmbHHTN2015-09-30
07613327074215VARIAXStryker GmbHHTN2015-09-30
07613327074239VARIAXStryker GmbHHTN2015-09-30