FDA.reportPublic FDA data

VARIAX

Primary DI
07613327069853
Brand
VARIAX
Company
Stryker GmbH
Model
703690
Catalog number
703690
Device description
Drill Bit, AO Dia2.0mm x 135mm, Scaled
Published
2016-09-24
Public version status
Update
Distribution status
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
07613327069853PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07613327069853076133270698537613327069853

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Length135Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
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