FDA.reportPublic FDA data

TRACKER

Primary DI
10886705006625
Brand
TRACKER
Company
DEPUY MITEK, LLC
Model
219461
Catalog number
219461
Device description
TRACKER DRILL BIT 3.2mm x 17.8cm
Published
2015-09-01
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
HTWBIT, DRILL

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTWBit, DrillOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705006625PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500662510886705006625

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic guidewire, reusableA thin, non-implantable rod designed to guide the insertion of a cannulated orthopaedic implant (typically an intramedullary nail or screw) and/or surgical instrument (e.g., drill bit) during an orthopaedic procedure. It is made of metal and is available in a variety of sizes, lengths, and designs (e.g., round-tip, trocar-tip, or flexible-tip). This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(800)255-2500xx@xx.xx

Regulatory Flags#

DUNS number
190572854
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
10886705010684MILAGRO2318002318002015-09-01
10886705010738MILAGRO2318052318052015-09-01
10886705010776MILAGRO2318102318102015-09-01
10886705010783MILAGRO2318152318152015-09-01
10886705011049STRAIGHTSHOT2322152322152015-09-01
10886705011056STRAIGHTSHOT2322202322202015-09-01
10886705017836BRISTOW LATARJET2851802851802015-09-01
10886705022533BRISTOW LATARJET2851432851432015-09-01
10886705004980VERSALOK2154402154402015-09-01
10886705018178BRISTOW LATARJET2853452853452015-09-01
10886705025213EXPRESSEW2141592141592017-03-17
10886705002528QUICKANCHOR ETHIBOND TAPERCUT2128652128652015-09-01
10886705002535QUICKANCHOR ETHIBOND2128662128662015-09-01
10886705008223FASTIN ETHIBOND2227202227202015-09-01
10886705017454FMS2845492845492017-03-17
10886705023431HEALIX ADVANCE2223352223352015-09-01
10886705023455HEALIX ADVANCE2223332223332015-09-01
10886705023462HEALIX ADVANCE2223302223302015-09-01
10886705023479HEALIX ADVANCE2223312223312015-09-01
10886705023493HEALIX ADVANCE2223322223322015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10886982345431VOLTSynthes GmbHHTW2026-09-25
10886982345479VOLTSynthes GmbHHTW2026-09-25
00888867574540Arthrex®ARTHREX, INC.HTW2026-09-18
00888867574557Arthrex®ARTHREX, INC.HTW2026-09-18
10810128463079OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463086OSSIO® Threaded Trimmable Fixation Nail Instrument Pack W Drill Bit 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463185OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x70mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
10810128463192OSSIO® Threaded Trimmable Fixation Nail Instrument Pack 7.0x100mmT.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATIONHTW2026-08-23
00884450681381Preston™Merit Medical Systems, Inc.HTW2026-08-21
00884450681398Preston™Merit Medical Systems, Inc.HTW2026-08-21
00840606191791Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191807Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191814Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191821Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606191852Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195768Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00840606195775Overwatch PCFSPINAL ELEMENTS, INC.HTW2026-07-31
00190376544397InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544403InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544410InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544427InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544434InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544441InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544458InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544465InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544472InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544489InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544861InvictusALPHATEC SPINE, INC.HTW2026-07-30
00190376544878InvictusALPHATEC SPINE, INC.HTW2026-07-30
03701089515153AMPLITUDEAMPLITUDE SASHTW2026-07-29