FDA.reportPublic FDA data

Avanta CMC

Primary DI
00886385025773
Brand
Avanta CMC
Company
Stryker GmbH
Model
CMC-R
Device description
INSTRUMENT SET, AVANTA CMC
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
00886385025773PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385025773008863850257738863850257730886385025773

GMDN Terms#

Term, Definition table
TermDefinition
Joint prosthesis implantation kit, reusableA collection of surgical instruments used for cutting and forming bone to allow the implantation of a joint prosthesis. The instruments include various metallic and/or plastic reusable devices (e.g., retractors, rods, clamps, drills, pins, saws, guides, cutting blocks) that are specific to the joint of application (e.g., hip, knee, shoulder, ankle, or elbow); the implant(s) is not included. This is a reusable device.

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
DM exempt
true
Kit
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00886385017365STAR908-0110-02908-0110-022022-02-14
00886385018836STAR933-0003-02933-0003-022022-02-14
00886385018843STAR933-0003-03933-0003-032022-02-14
00886385019055STAR933-0025-02933-0025-022022-02-14
00886385019062STAR933-0025-03933-0025-032022-02-14
00886385019147STAR933-0029-02933-0029-022022-02-14
00886385017150STAR905-0066905-00662020-09-24
07613327350296NA2351-00202351-00202018-11-02
07613327361650NA2351-01402351-01402018-11-02
07613327361667NA2351-03402351-03402018-11-02
07613327361674NA2351-00302351-00302018-11-02
07613327361681NA2351-00602351-00602018-11-02
07613327361780NA2351-42902351-42902018-11-02
07613327368154NA2351-00702351-00702018-11-02
07613327368178NA2351-42802351-42802018-11-02
07613327376197NA2351-04202351-04202018-11-01
07613327376203NA2351-03802351-03802018-11-01
00886385016412STAR™400-2502017-06-27
00886385016429STAR™400-2512017-06-27
00886385016436STAR™400-2522017-06-27

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
00886385025728Avanta CMCStryker GmbHKWG2017-06-27
00886385025735Avanta CMCStryker GmbHKWG2017-06-27
00886385025766Avanta 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