FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00824846010739
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0626003
Device description
TAP X0626003 3.5MM
Published
2026-10-18
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWXTAP, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00824846010739PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00824846010739008248460107398248460107390824846010739

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)633-8766Corporate.UDI@medtronic.com

Regulatory Flags#

DUNS number
830350380
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00199150076451Medtronic Reusable InstrumentsX36902502026-10-19
00199150080373Medtronic Reusable InstrumentsX02260452026-10-19
00199150080380Medtronic Reusable InstrumentsX02260462026-10-19
00199150080397Medtronic Reusable InstrumentsX02260472026-10-19
00199150080403Medtronic Reusable InstrumentsX02260502026-10-19
00824846003922Medtronic Reusable InstrumentsEX06260022026-10-19
00824846013082Medtronic Reusable InstrumentsX09074302026-10-19
00824846013600Medtronic Reusable InstrumentsX07260042026-10-19
00763000750053CD HORIZON® Fenestrated Screw Spinal System557510245402026-10-16
00763000750251CD HORIZON® Fenestrated Screw Spinal System557510255302026-10-16
00763000750268CD HORIZON® Fenestrated Screw Spinal System557510255352026-10-16
00763000750275CD HORIZON® Fenestrated Screw Spinal System557510255402026-10-16
00763000750374CD HORIZON® Fenestrated Screw Spinal System557510265352026-10-16
00763000750404CD HORIZON® Fenestrated Screw Spinal System557510265502026-10-16
00824846013495Medtronic Reusable InstrumentsEX07260062026-10-18
00763000786458CD HORIZON® Fenestrated Screw Spinal System65411012026-10-15
00643169236967n/a74806532026-10-11
00643169236974n/a74806522026-10-11
00643169236981n/a74806512026-10-11
00763000857851T2 STRATOSPHERE™ Expandable Corpectomy System43612582026-10-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800308479070ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
08800308479094ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
08800308479117ANAX™ 5.5 CT SPINAL SYSTEMCG MedTech Co.,Ltd.HWX2026-08-19
00840606191883Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606191890Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606191906Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195782Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195799Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195805Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
00840606195812Overwatch PCFSPINAL ELEMENTS, INC.HWX2026-07-31
07290019361343OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361350OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361367OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361374OSSIO® TapOSSIO LTDHWX2026-07-19
07290019361381OSSIO® TapOSSIO LTDHWX2026-07-19
18257200076581CETRAOrthofix US LLCHWX2026-07-17
18257200076604CETRAOrthofix US LLCHWX2026-07-17
18257200076611CETRAOrthofix US LLCHWX2026-07-17
18257200076628CETRAOrthofix US LLCHWX2026-07-17
09120125220280Shark Screw® tapsurgebright GmbHHWX2026-04-30
10705034577913N/AMedos International SàrlHWX2026-04-23
10705034577920N/AMedos International SàrlHWX2026-04-23
10705034577937N/AMedos International SàrlHWX2026-04-23
10705034577944N/AMedos International SàrlHWX2026-04-23
10705034577951N/AMedos International SàrlHWX2026-04-23
10705034577968N/AMedos International SàrlHWX2026-04-23
10705034577975N/AMedos International SàrlHWX2026-04-23
10705034577982N/AMedos International SàrlHWX2026-04-23
10705034577999N/AMedos International SàrlHWX2026-04-23
G079C5020000950Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22