FDA.reportPublic FDA data

STAR

Primary DI
00886385017365
Brand
STAR
Company
Stryker GmbH
Model
908-0110-02
Catalog number
908-0110-02
Device description
Captive Screw, Drill Guide
Published
2022-02-14
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
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
00886385017365PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00886385017365008863850173658863850173650886385017365

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
481999654
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327616859HOFFMANN LRF4936-0-1304936-0-1302026-07-23
07613327616880HOFFMANN LRF4936-1-3054936-1-3052026-07-23
07613327649109T2, PANGEA5431405431402025-09-25
07613327649130T2, PANGEA5431705431702025-09-25
07613327649253T2, PANGEA6497-1-0606497-1-0602025-09-25
07613327649260T2, PANGEA6497-1-0706497-1-0702025-09-25
07613327649277T2, PANGEA6497-1-070S6497-1-070S2025-09-25
07613327649284T2, PANGEA6497-1-060S6497-1-060S2025-09-25
07613327649291T2, PANGEA6497-1-0806497-1-0802025-09-25
07613327649307T2, PANGEA6497-1-0906497-1-0902025-09-25
07613327649314T2, PANGEA6497-1-080S6497-1-080S2025-09-25
07613327649321T2, PANGEA6497-1-090S6497-1-090S2025-09-25
07613327649338T2, PANGEA6497-1-1006497-1-1002025-09-25
07613327649345T2, PANGEA6497-1-1106497-1-1102025-09-25
07613327649352T2, PANGEA6497-1-100S6497-1-100S2025-09-25
07613327649369T2, PANGEA6497-1-110S6497-1-110S2025-09-25
07613327649376T2, PANGEA6497-1-1306497-1-1302025-09-25
07613327649383T2, PANGEA6497-1-130S6497-1-130S2025-09-25
07613327649390T2, PANGEA6497-1-120S6497-1-120S2025-09-25
07613327649406T2, PANGEA6497-1-1206497-1-1202025-09-25

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
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
B095300506Hintermann Series H3Dt Medtech, LLCNTG2019-08-20