FDA.reportPublic FDA data

VARIAX

Primary DI
04546540694294
Brand
VARIAX
Company
Stryker GmbH
Model
703705
Catalog number
703705
Device description
Tap AO Fitting
Published
2016-09-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
LXHOrthopedic Manual Surgical Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170727000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170727000VariAx 2 Compression Plating SystemStryker GmbH2017-06-22HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540694294PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540694294045465406942944546540694294

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable 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
DM exempt
true
Premarket exempt
true
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
M9432002220000MinutemanSpinal Simplicity, LLCLXH2026-09-04
07613327697209PANGEAStryker GmbHLXH2026-08-27
10888857599710YUKON OCT Spinal SystemVB Spine LLCLXH2026-08-25
10888857613812K2M General InstrumentsVB Spine LLCLXH2026-06-12
10888857613805Xia® 3VB Spine LLCLXH2026-06-11
10888857596900OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596917OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596924OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596931OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
10888857596948OZARK Cervical Plate SystemVB Spine LLCLXH2026-05-01
07640176970740Resection CheckerNaviswiss AGLXH2025-08-12
07640176970108Set of NAVItags (sterile, single-use)Naviswiss AGLXH2024-05-16
07640176970115Tag adapter PNaviswiss AGLXH2024-05-16
07640176970122Tag adapter M (magnetic)Naviswiss AGLXH2024-05-16
07640176970153Hex screwdriver SW3.5mm (AO coupling)Naviswiss AGLXH2024-05-16
07640176970177Tag adapter FNaviswiss AGLXH2024-05-16
07640176970191Pelvic caliperNaviswiss AGLXH2024-05-16
07640176970214Speed pin (3.0 x 80 mm, wear part)Naviswiss AGLXH2024-05-16
07640176970221Speed pin adapterNaviswiss AGLXH2024-05-16
07640176970238Cortical bone screwNaviswiss AGLXH2024-05-16
07640176970252Calibration barNaviswiss AGLXH2024-05-16
07640176970320Tag adapter M (quick-lock)Naviswiss AGLXH2024-05-16
07640176970337PointerNaviswiss AGLXH2024-05-16
07640176970375Hex screwdriver SW3.5mm spherical headNaviswiss AGLXH2024-05-16
07640176970467Cortical bone screw (self drilling, 3.5 x 23 mm, wear part)Naviswiss AGLXH2024-05-16
07640176970481Single-pin tag mount (self-drilling, wear part)Naviswiss AGLXH2024-05-16
07640176970498Single-pin tag mount AO adapterNaviswiss AGLXH2024-05-16
07640176970511Speed pin (3.0 x 110 mm, wear part)Naviswiss AGLXH2024-05-16
07640176970542Acetabular Adapter PNaviswiss AGLXH2024-05-16
07640176970610Single-pin tag mount short (self drilling, wear part)Naviswiss AGLXH2024-05-16