FDA.reportPublic FDA data

Avanta CMC

Primary DI
00886385025728
Brand
Avanta CMC
Company
Stryker GmbH
Model
17-0486
Device description
CMC, Trapezial Burr Size 20, 6mm
Published
2017-06-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWGProsthesis, Finger, Constrained, Metal/Polymer

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWGProsthesis, Finger, Constrained, Metal/PolymerOrthopedic3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886385025728PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385025728008863850257288863850257280886385025728

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bur, reusableA rotary cutting device consisting of a shaft of high-grade steel and a cutting head of hard metal/material with fluting or cutting planes of various shapes at the working end and which is designed to fit into an appropriate powered handpiece that provides the rotation allowing the user to excavate/shape bone tissue during small and large bone surgery (e.g., maxillofacial, spinal, or orthopaedic). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter6Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
1-201-831-5000xx@xx.xx

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
00886385025759Avanta CMCStryker GmbHKWG2017-07-19
00886385025650Avanta CMCStryker GmbHKWG2017-06-27
00886385025667Avanta CMCStryker GmbHKWG2017-06-27
00886385025674Avanta CMCStryker GmbHKWG2017-06-27
00886385025698Avanta CMCStryker GmbHKWG2017-06-27
00886385025704Avanta CMCStryker GmbHKWG2017-06-27
00886385025711Avanta CMCStryker GmbHKWG2017-06-27
00886385025735Avanta CMCStryker GmbHKWG2017-06-27
00886385025766Avanta CMCStryker GmbHKWG2017-06-27
00886385025773Avanta CMCStryker GmbHKWG2017-06-27
00886385025797Avanta CMCStryker GmbHKWG2017-06-27
08806189800040Lnk Spinal Fixation SystemL&K BIOMED CO. ,LTD.KWG2014-09-23
00886385025780Avanta CMCStryker GmbHKWG2014-09-19