FDA.reportPublic FDA data

NA

Primary DI
10886705006250
Brand
NA
Company
DEPUY MITEK, LLC
Model
219400
Catalog number
219400
Device description
CORTICAL TAP For use with Mitek Cortical Screws 4.5mm
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
LXHORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10886705006250PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088670500625010886705006250

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA surgical instrument designed for cutting internal threads into bone, so that the threads facilitate the insertion of bone screws (not included). The screws may be used to anchor bone fragments, fixtures and/or other devices to the bone. It is typically manually rotated and consists of a metal shaft with a helical thread which may be cannulated or intersected with longitudinal cutting grooves. 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
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
10886705010684MILAGRO2318002318002015-09-01
10886705010738MILAGRO2318052318052015-09-01
10886705010776MILAGRO2318102318102015-09-01
10886705010783MILAGRO2318152318152015-09-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810166522816Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522823Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522830Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522847Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522854Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522861Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00810166522878Expanding InnovationsEXPANDING INNOVATIONS, INC.LXH2026-05-27
00889929072424Matrixx SystemNEXXT SPINE, LLCLXH2026-05-27
07640187918809Straight reamer handleMPS Micro Precision Systems AGLXH2026-05-27
07613327007114ES2 SPINAL SYSTEMStryker CorporationLXH2019-11-25
07613327007558XIA 3Stryker CorporationLXH2019-11-25
07613327007565XIA 3Stryker CorporationLXH2019-11-25
07613327114881XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327121919XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327126273AVS Anchor-C Cervical Cage SystemStryker CorporationLXH2019-11-25
07613327142662XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327142679XIA 4.5 EVOLUTIONStryker CorporationLXH2019-11-25
07613327177480OASYSStryker CorporationLXH2019-11-25
07613327261752DIAPASONStryker CorporationLXH2019-11-25
07613327261943O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261950O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261967O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261974O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327261998O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262001O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262018O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262025O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262032O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262049O.I.C. TITANIUMStryker CorporationLXH2019-11-25
07613327262056O.I.C. TITANIUMStryker CorporationLXH2019-11-25