FDA.reportPublic FDA data

Stryker

Primary DI
B504OM16089870
Brand
Stryker
Company
Provision
Model
1608-9-87
Published
2018-09-10
Public version status
New
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
HTTBurr, Orthopedic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTTBurr, OrthopedicOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B504OM16089870PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Burring power tool attachmentA device intended to connect to a surgical power tool system motor [it is locked and held in a collet or quick coupling and not simply gripped in a drill chuck (Jacobs chuck)] to convert the non-dedicated mechanical energy provided by the motor to a dedicated mechanical motion to perform a burring function when an appropriate bur is inserted. It may include integral design features, e.g., have an angled head or have an extended body length to better suit a particular activity. It is typically made of high-grade stainless steel and synthetic materials. The device may be of the micro or macro design. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
541-480-7953customersupport@provisiondrs.c

Regulatory Flags#

DUNS number
016889401
Device count
1
DM exempt
true
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B504OM4515700130DePuy Mitek4515700132026-03-19
B504OM50715940Conmed Linvatec5071-5942026-03-19
B504OMDC119090180Conmed LinvatecDC119-090-182026-03-19
B504OM50711330ConMed Linvatec5071-1332026-02-24
B504OM50721010ConMed Linvatec5072-1012026-02-24
B504OMBR58201070250BrasselerBR5820-107-0252026-02-24
B504OMPDS2NL300NakanishiPDS-2NL-302026-02-09
B504OM13090119XG10Zimmer13090119XG12025-11-25
B504OM19100119XG10Zimmer19100119XG12025-11-25
B504OM20090119XC10Zimmer20090119XC12025-11-25
B504OM20100119XC10Zimmer20100119XC12025-11-25
B504OM20100119XCW0Zimmer20100119XCW2025-11-25
B504OM21090119XGW0Zimmer21090119XGW2025-11-25
B504AE2273010DePuy Mitek 2273012018-04-05
B504AE2273020DePuy Mitek 2273022018-04-05
B504AE2273050DePuy Mitek 2273052018-04-05
B504CBEICA5874010Smith & NephewEICA5874-012018-04-03
B504CBEICA8875010Smith & NephewEICA8875-012018-04-03
B504CBEICA8898010Smith & NephewEICA8898-012018-04-03
B504EICA9820010Smith & NephewEICA9820-012019-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B390030001131Reprocessed 2.3mm Lindemann ReamerSURETEK MEDICALHTT2025-07-18
08057717551020SHANNON STD BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551082SHANNON ISHAM BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551143CONICAL BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551204CONICAL BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551266CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551327CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551389CYLINDRICAL STRAIGHT BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551457WEDGE BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551525WEDGE BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551587ROUNDED BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551648ROUNDED BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717551709BROPHY BURRBRM EXTREMITIES SRLHTT2025-04-04
08057717550962SHANNON SHORT BURRBRM EXTREMITIES SRLHTT2025-03-27
B504OM0228013S0BrasselerProvisionHTT2025-02-05
B504OM030000170SynthesProvisionHTT2025-02-05
B504OM030000700SynthesProvisionHTT2025-02-05
B504OM03228015S0BrasselerProvisionHTT2025-02-05
B504OM03228017S0BrasselerProvisionHTT2025-02-05
B504OM04C03060BrasselerProvisionHTT2024-08-08
B504OM5300107140StrykerProvisionHTT2024-08-08
B504OM5300309010StrykerProvisionHTT2024-08-08
B504OM58200800210StrykerProvisionHTT2024-08-08
00840124512801FuzeFix Chamfered ScrewsFUSION ORTHOPEDICS, LLCHTT2024-06-27
B504OMAR300B1010ArthrexProvisionHTT2024-06-10
B504OM5300105070StrykerProvisionHTT2024-05-28
B504OM13750520ConMedProvisionHTT2024-05-22
B504OM13750530ConMedProvisionHTT2024-05-22
B504OMDW311055R0VilexProvisionHTT2024-05-22
B504OM50911020ConMedProvisionHTT2024-05-16