FDA.reportPublic FDA data

Arsenal

Primary DI
00844856055148
Brand
Arsenal
Company
ALPHATEC SPINE, INC.
Model
87527-45
Device description
CBX PEDICLE MARKER TAP, 4.5mm
Published
2020-06-17
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
HWXTAP, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWXTap, BoneOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00844856055148PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00844856055148008448560551488448560551480844856055148

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(760)431-9286Regulatory@alphatecspine.com

Regulatory Flags#

DUNS number
602465783
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
00190376541471ATEC Lateral Navigation Disc Prep Instruments267-01-000-10-N2024-12-18
00190376529158ATEC Posterior Navigation Disc Prep Instruments244-01-000-06-N2024-04-20
00190376529189ATEC Posterior Navigation Disc Prep Instruments244-01-000-12-N2024-04-20
00190376476162ATEC Lateral Navigation Disc Prep Instruments266-01-000-08-N2023-08-26
00190376476179ATEC Lateral Navigation Disc Prep Instruments266-01-000-10-N2023-08-26
00190376476186ATEC Lateral Navigation Disc Prep Instruments266-01-000-12-N2023-08-26
00190376522906ATEC Lateral Navigation Disc Prep Instruments266-01-000-14-N2023-08-26
00840180512395General InstrumentsCI-11129-34242026-05-15
00840180543214General InstrumentsCI-118992026-05-15
00840180543542General InstrumentsCI-11915-302026-05-15
00840180544785General InstrumentsCI-11939-080-R2026-05-15
00840180544914General InstrumentsCI-11939-080-L2026-05-15
00840180545324General InstrumentsCI-11968-06-S2026-05-15
00840180545331General InstrumentsCI-11968-06-L2026-05-15
00840180545362General InstrumentsCI-11968-S2026-05-15
00840180545416General InstrumentsCI-11972-012026-05-15
00840180545423General InstrumentsCI-11972-032026-05-15
00840180545430General InstrumentsCI-11972-022026-05-15
00840180545447General InstrumentsCI-11972-042026-05-15
00840180545461General InstrumentsCI-11969-L2026-05-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G832F00503450ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
G832F00503550ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
G832F00503650ACURA Stabilization SystemBioalign Inc.HWX2026-03-09
03662663131674Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131681Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131698Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131704Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131711Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131728Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131735Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131803Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131810Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131827Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
03662663131834Polaris 5.5 Spinal Fixation SystemHighridge Medical, LLCHWX2026-02-11
10886982351661NASynthes GmbHHWX2026-02-11
10886982351678NASynthes GmbHHWX2026-02-11
00810112597417TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
00810112597424TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
00810112597431TriLeap Lower Extremity Anatomic Plating SystemCROSSROADS EXTREMITY SYSTEMSHWX2026-02-10
07640177821324Neo Medical Pedicle screw kitNeo Medical SAHWX2026-02-09
00199150055296Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-26
00199150055227Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055234Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055241Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055258Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055265Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055272Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055289Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055302Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25
00199150055319Medtronic Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.HWX2025-12-25