FDA.reportPublic FDA data

STAR

Primary DI
00886385017068
Brand
STAR
Company
Stryker GmbH
Model
903-0032
Device description
RASP ASSEMBLY
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
NTGProsthesis, Ankle, Uncemented, Non-Constrained

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NTGProsthesis, Ankle, Uncemented, Non-ConstrainedUnknown3

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00886385017068PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385017068008863850170688863850170680886385017068

GMDN Terms#

Term, Definition table
TermDefinition
Bone file/rasp, manualA hand-held manual surgical instrument with a surface(s) of coarse and/or fine grooves or teeth designed to scrape and smooth the surface of bone during a surgical procedure. The device is typically a one-piece instrument with grooves/teeth along all or part of its working end(s). It is available in a variety of sizes and working end designs, including straight and curved ends and often double-ended with a central handle. It is not dedicated for use at a specific anatomy (e.g., sinus, ear) and it is made of metal [e.g., stainless steel, titanium (Ti)]. 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
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327605716PANGEA5422525422522026-06-02
07613327648331PANGEA5421605421602026-06-02
07613327648355PANGEA7039197039192026-06-02
07613327648362PANGEA5421615421612026-06-02
07613327648379PANGEA7039187039182026-06-02
37613153159729PROFYLE59-1204959-120492015-09-24
37613153159736PROFYLE59-1704959-170492015-06-24
37613153159743PROFYLE59-2304959-230492015-07-03
07613154583829PROFYLE59-12049E59-12049E2015-06-24
07613154583836PROFYLE59-17049E59-17049E2015-06-24
07613154583843PROFYLE59-23049E59-23049E2015-07-03
07613327625066PANGEA5421165421162024-12-01
00886385019741SR PIP17-13152017-06-27
00886385019758SR PIP17-13162017-06-27
00886385019765SR PIP17-13172017-06-27
00886385019772SR PIP17-13182017-06-27
00886385019789SR PIP17-13192017-06-27
00886385019796SR PIP17-13202017-06-27
00886385019802SR PIP17-13212017-06-27
00886385019819SR PIP17-13222017-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850062461949Tibial Impactor Tips Trilliant Surgical, LLCNTG2024-08-09
008100283934796mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
008100283934867mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
008100283934938mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
008100283935099mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839351610mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839352311mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839353012mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839354713mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0081002839355414mm STAR E+ Sliding Core STAR Total AnkleTrilliant Surgical, LLCNTG2024-08-06
0085006246136914mm E+ Slide Core STAR ImplantTrilliant Surgical, LLCNTG2024-08-06
B095301201Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301202Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301203Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301204Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301205Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
B095301206Hintermann Series H3Dt Medtech, LLCNTG2024-02-20
00810028393431STAR PSI Tibia Cut GuideTrilliant Surgical, LLCNTG2022-11-30
00810028393448STAR PSI Tibia Anatomical ModelTrilliant Surgical, LLCNTG2022-11-30
00810028393455STAR PSI Talus Cut GuideTrilliant Surgical, LLCNTG2022-11-30
00810028393462STAR PSI Talus Anatomical ModelTrilliant Surgical, LLCNTG2022-11-30
00810028394971STAR PSI Standard Bundle with Anatomical ModelsTrilliant Surgical, LLCNTG2022-11-30
00886385017365STARStryker GmbHNTG2022-02-14
00886385018836STARStryker GmbHNTG2022-02-14
00886385018843STARStryker GmbHNTG2022-02-14
00886385019055STARStryker GmbHNTG2022-02-14
00886385019062STARStryker GmbHNTG2022-02-14
00886385019147STARStryker GmbHNTG2022-02-14
B095302113Hintermann Series H3Dt Medtech, LLCNTG2019-08-20
B095302125Hintermann Series H3Dt Medtech, LLCNTG2019-08-20