NA

Primary DI
07613327088359
Brand
NA
Company
Stryker GmbH
Model
390000
Catalog number
390000
Device description
Nut
Published
2015-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HRSPLATE, FIXATION, BONE
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K012162000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K012162000STRYKER PLATING SYSTEM BASIC FRAGMENT SETHowmedica Osteonics Corp.2001-08-31HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327088359PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327088359076133270883597613327088359

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone nutA sterile profiled block made of metallic or non-metallic material that is threaded on its inside surface, and designed to securely fasten a bone fixation bolt, possibly with a washer. This is a single-use device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327697209PANGEASIT0007195SIT00071952026-08-27
07613327414127PANGEA706408S706408S2023-06-13
07613327415582PANGEA706407S706407S2023-06-13
07613327416138PANGEA706406S706406S2023-06-13
07613327539585PANGEA706444S706444S2023-06-13
07613327541731PANGEA703551S703551S2023-06-13
07613327541748PANGEA703555S703555S2023-06-13
07613154969357VARIAX45-35015S45-35015S2020-09-24
04546540195913NA1806-0083S1806-0083S2020-04-07
04546540195937NA1806-0085S1806-0085S2020-04-07
04546540195951NA1806-0090S1806-0090S2020-04-07
04546540195975NA1806-0093S1806-0093S2020-04-07
07613154633326NA45-20011S45-20011S2018-09-24
07613154633432NA45-30011S45-30011S2018-09-24
07613154665891NA45-20001S45-20001S2018-09-24
07613154665907NA45-20004S45-20004S2018-09-24
07613154665914NA45-30001S45-30001S2018-09-24
07613154665921NA45-30004S45-30004S2018-09-24
07613327083286AXSOS705077S705077S2016-09-24
07613327083323AXSOS705078S705078S2016-09-24

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885556836170Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836194Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836200Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836217Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836224Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836248Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836255Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836262Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835999Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836002Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836019Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836026Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836033Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836040Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836057Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836064Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836071Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836088Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836095Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836118Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836125Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836132Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836149Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836156Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556838785Total Foot System 2Smith & Nephew, Inc.HRS2022-12-21
00885556838785Total Foot System 2Smith & Nephew, Inc.HWC2022-12-21
00888867007475Arthrex®ARTHREX, INC.HRS2017-02-15
00888867007499Arthrex®ARTHREX, INC.HRS2017-02-15