FDA.reportPublic FDA data

ASNIS

Primary DI
07613327522143
Brand
ASNIS
Company
Stryker GmbH
Model
619990
Catalog number
619990
Device description
Washer
Published
2022-06-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTNWASHER, BOLT NUT
HWCScrew, fixation, bone
OURSacroiliac joint fixation

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2
OURSacroiliac Joint FixationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220319000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220319000Asnis III Cannulated Screw System, Asnis PRO Cannulated Screw SystemStryker GmbH2022-06-10HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07613327522143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327522143076133275221437613327522143

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810131884055TiLink-L Rescue Drill GuideSurgentec, LLCOUR2026-09-25
00810131884062TiLink-L Rescue DilatorSurgentec, LLCOUR2026-09-25
00810131884079TiLink-L Rescue Impact CapSurgentec, LLCOUR2026-09-25
00810131884086TiLink-L Rescue screw Drill bit – 10.5mmSurgentec, LLCOUR2026-09-25
00810131884857TiLink-L Sterilization Tray – Double StackSurgentec, LLCOUR2026-09-25
00810131884864TiLink-L Rescue CaddySurgentec, LLCOUR2026-09-25
00842188131615CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131639CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131653CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131677CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00842188131721CannCompScrew 5.5 (Ti)Trimed, INC.HWC2026-09-25
00889095401820ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401844ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401868ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401882ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401905ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095401929ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402285ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402438ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402483ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095402537ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411263ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411287ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411300ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095411324ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
00889095611274ANTHEMGLOBUS MEDICAL, INC.HWC2026-09-25
10886982342508VOLTSynthes GmbHHWC2026-09-25
10886982342515VOLTSynthes GmbHHWC2026-09-25
10886982342522VOLTSynthes GmbHHWC2026-09-25
10886982342539VOLTSynthes GmbHHWC2026-09-25