FDA.reportPublic FDA data

NA

Primary DI
04546540755360
Brand
NA
Company
STRYKER CORPORATION
Model
234-020-018
Catalog number
234-020-018
Device description
12MM CORE DRILL TIBIAL
Published
2015-09-04
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
HTOREAMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTOReamerOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04546540755360PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04546540755360045465407553604546540755360

GMDN Terms#

Term, Definition table
TermDefinition
Bone-resection orthopaedic reamer, reusableAn orthopaedic surgical instrument designed to resect (cut out part of the bone) and precisely shape a specific area of bone for the acceptance of a prosthetic implant, typically at or within a joint (e.g., condyle of knee, neck of humerus, olecranon of ulna). It is commonly called a mill or a reamer and is typically designed as either a preshaped or a solid cylindrical body with an end or circumferential cutting edge. It is attached to a shaft for manual or powered rotation and may be steered over a guide or spigot that has been inserted into the site to control the cutting action. It is typically made of a high-grade stainless steel alloy in varying sizes. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(866)624-4422xx@xx.xx

Regulatory Flags#

DUNS number
187502109
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07613327652703N/A72000152707200-015-2702026-04-15
07613327652710PROstep72000150437200-015-0432026-04-13
07613327652727N/A72010157107201-015-7102026-04-13
07613327652734N/A72000153707200-015-3702026-04-13
07613154599127NA59200002045920-000-2042018-09-24
07613327413281Connected OR Hub02402001000240-200-1002023-07-26
07613327051674AIM SafeLight02330503000233-050-3002016-09-23
07613327056167SDC3024006010102400601012016-09-23
07613327056174SDC3024006010202400601022016-09-23
07613327382389168816880201221688-020-1222019-01-17
07613327405910Precision IE 4K0502-444-0700502-444-0702019-01-21
07613327405927Precision IE 4K0502-445-0300502-445-0302019-01-21
07613327405934Precision IE 4K0502-444-0100502-444-0102019-01-21
07613327405941Precision IE 4K0502-445-0700502-445-0702019-01-21
07613327405958Precision IE 4K0502-444-0300502-444-0302019-01-21
07613327405965Precision IE 4K0502-445-0100502-445-0102019-01-21
07613327405972Precision IE 4K0502-444-0450502-444-0452019-01-21
07613327405989Precision IE 4K0502-444-1300502-444-1302019-01-21
07613327416299Precision IE 4K0502-194-0100502-194-0102019-01-21
07613327416305Precision IE 4K0502-194-0300502-194-0302019-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810094692797Tibial Reamer, Square Tip, Klassic ONE 25/50mmTOTAL JOINT ORTHOPEDICS, INC.HTO2026-06-09
00810030810575InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810582InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810599InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810605InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810612InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810629InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810636InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810643InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810650InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810667InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810674InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810681InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810698InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810704InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-06-01
00810030810414InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810421InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810438InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810445InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810452InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810469InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810476InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810483InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810490InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810506InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810513InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810520InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810537InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810544InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31
00810030810551InSitu Hip SystemNEXTSTEP ARTHROPEDIX, LLCHTO2026-05-31