FDA.reportPublic FDA data

Accu-Joint

Primary DI
00850044114849
Brand
Accu-Joint
Company
Accufix Surgical, Inc.
Model
AJIT 4.0-20
Catalog number
AJIT 4.0-20
Device description
4.0mm Accu-Joint Hemi Implant Tap
Published
2022-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
00850044114849PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044114849008500441148498500441148490850044114849

GMDN Terms#

Term, Definition table
TermDefinition
Bone tap, reusableA metal surgical instrument designed for cutting internal threads into bone so that the threads facilitate the insertion of bone screws. The screws anchor bone fragments, fixtures and/or other devices to the bone. It is made of high-grade stainless steel and has a helical thread intersected with longitudinal cutting grooves forming the cutting edges at its distal end and may be cannulated. The proximal end typically terminates in a square to which a tapping instrument or extension can be attached. It will typically be manually rotated in order to create a best possible thread. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
045694474
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
00850044114962Accu-JointAJMI-10-20-2AJMI-10-20-22024-11-11
00850044114979Accu-JointAJMT-10-2-TAJMT-10-2-T2024-11-11
00850044114986Accu-JointAJMS-16-2-SAJMS-16-2-S2024-11-11
00850044114993Accu-JointAJMS-14-2-SAJMS-14-2-S2024-11-11
00850061635006Accu-JointAJMS-12-2-SAJMS-12-2-S2024-11-11
00850061635013Accu-JointAJMS-18-2-SAJMS-18-2-S2024-11-11
00850061635020Accu-JointAJMT-18-2-TAJMT-18-2-T2024-11-11
00850061635037Accu-JointAJMI-18-20-2AJMI-18-20-22024-11-11
00850061635044Accu-JointAJMS-10-2-SAJMS-10-2-S2024-11-11
00850061635051Accu-JointACFX2023-1ACFX2023-12024-11-11
00850061635082Accu-JointAJMS-10-SAJMS-10-S2024-11-11
00850061635099Accu-JointAJMS-9-SAJMS-9-S2024-11-11
00850061635105Accu-JointAJMS-11-SAJMS-11-S2024-11-11
00850061635112Accu-JointAJPS-8-SAJPS-8-S2024-11-11
00850061635129Accu-JointAJPS-9-SAJPS-9-S2024-11-11
00850061635136Accu-JointAJPS-10-SAJPS-10-S2024-11-11
00850061635143Accu-JointAJPS-11-SAJPS-11-S2024-11-11
00850061635150Accu-JointAJPS-13-SAJPS-13-S2024-11-11
00850061635167Accu-JointAJPS-15-SAJPS-15-S2024-11-11
00850061635174Accu-JointAJPS-17-SAJPS-17-S2024-11-11

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
G079C5020001000Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
G079C5020001050Golden Isles Pedicle Screw SystemIntelivation, LLCHWX2026-04-22
08800322758182Anyplus ll Spinal Fixation SystemGS Medical Co., Ltd.HWX2026-04-21