FDA.reportPublic FDA data

Avanta CMC

Primary DI
00886385025759
Brand
Avanta CMC
Company
Stryker GmbH
Model
CMC-M20
Device description
CMC, METACARPAL, SIZE 20
Published
2017-07-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
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
00886385025759PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385025759008863850257598863850257590886385025759

GMDN Terms#

Term, Definition table
TermDefinition
Carpal trapezium prosthesisA sterile implantable device designed to replace a partly-resected trapezium bone of the wrist typically to treat thumb instability/motion disabilities caused by arthritis or fracture. It is typically a one-piece device made of silicone elastomer. Short-term fixation is typically performed with sutures.

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to direct sunlight or dampness

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
481999654
Device count
1
Lot or batch
true
Expiration date on label
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
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
00886385025728Avanta 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