FDA.reportPublic FDA data

Medtronic Reusable Instruments

Primary DI
00643169060760
Brand
Medtronic Reusable Instruments
Company
MEDTRONIC SOFAMOR DANEK, INC.
Model
X0711580
Device description
TAP X0711580 3.5MM TAPERED SHAFT
Published
2022-10-07
Public version status
Update
Distribution status
Not 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
00643169060760PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00643169060760006431690607606431690607600643169060760

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
00199150081073Medtronic Reusable InstrumentsX04260042026-07-30
20763000211015Medtronic Reusable Instrument65501022022-10-16
20763000211039Medtronic Reusable Instrument65502022022-10-16
00763000311667KYPHON® Directional Bone Filler DeviceF04C2020-11-06
00763000311681KYPHON® EXPRESS™ Bone Filler DeviceF06A2020-11-06
00763000311698KYPHON® EXPRESS™ Directional Bone Filler DeviceF06B2020-11-06
0076300031183413 Ga TampVPT02A2020-11-06
00763000883478N/a7480757T2025-06-01
00763000883485N/a7480758T2025-06-01
00763000711993N/A65500422024-12-28
00763000712006N/A65500432024-12-28
00763000712013N/A65500442024-12-28
00763000712020n/a65500452024-12-28
00763000311650KYPHON® Bone Filler Device (BFD)F04B2020-11-06
20643169842735KYPHON ELEMENT™ Balloon Kyphoplasty System7480703T2023-06-03
00613994946393n/aEX08108162022-11-21
00643169100725Medtronic Reusable InstrumentsCDS3A2022-10-15
00643169100749Medtronic Reusable InstrumentsCDS2A2022-10-15
00643169100756KYPHON® Cement Delivery SystemCC02A2022-10-15
00763000590970Kyphon VuE Bone Cement and Kyphon MixerCT01B2022-07-25

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078115596Jones UnionEXTREMITY MEDICAL, LLCHWX2026-10-29
00842078115602Jones UnionEXTREMITY MEDICAL, LLCHWX2026-10-29
00842078115619Jones UnionEXTREMITY MEDICAL, LLCHWX2026-10-29
00842078126097APEXEXTREMITY MEDICAL, LLCHWX2026-10-29
00190776436926MillenniumAvalign Technologies, Inc.HWX2026-10-23
00824846010739Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2026-10-18
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