FDA.reportPublic FDA data

Arsenal

Primary DI
00840967198286
Brand
Arsenal
Company
ALPHATEC SPINE, INC.
Model
87054
Device description
MODULAR TAP TIP, MODULAR HINGED DISTRACTOR
Published
2020-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HTDFORCEPS

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTDForcepsGeneral, Plastic Surgery1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840967198286PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840967198286008409671982868409671982860840967198286

GMDN Terms#

Term, Definition table
TermDefinition
Bone distraction forcepsA hand-held, manual, open-surgery instrument with sturdy handles and blade-like jaws designed to distract (force apart) two bone surfaces to enable a surgical procedure, e.g., two vertebrae during a spinal surgical intervention. It has a scissors-like lever action with straight or curved handles and is typically made of high-grade stainless steel. It is available in various sizes with the distraction blades at the working end which are activated through a single or double-jointed pivot that transfers the necessary force to create distraction; the blades are typically short and slender to fit between bone segments or pre-implanted pedicle screws. 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
00190376544397Invictus17920-012026-07-30
00190376544403Invictus17920-022026-07-30
00190376544410Invictus17920-032026-07-30
00190376544427Invictus17920-042026-07-30
00190376544434Invictus17920-052026-07-30
00190376544441Invictus17920-062026-07-30
00190376544458Invictus17920-072026-07-30
00190376544465Invictus17920-082026-07-30
00190376544472Invictus17920-092026-07-30
00190376544489Invictus17920-102026-07-30
00190376544496Invictus179212026-07-30
00190376544502Invictus179222026-07-30
00190376544519Invictus179242026-07-30
00190376544861Invictus17920-112026-07-30
00190376544878Invictus17920-122026-07-30
00190376766133InvictusVMDCORT2026-07-30
00190376732008Segmental Plating System338-0214-S2026-07-27
00190376732015Segmental Plating System338-0215-S2026-07-27
00190376732022Segmental Plating System338-0216-S2026-07-27
00190376732039Segmental Plating System338-0217-S2026-07-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00190776424503MillenniumAvalign Technologies, Inc.HTD2026-08-07
00841435122925TecometTECOMET INC.HTD2026-08-07
B382SD902508070Surgical DirectSurgical Direct, Inc.HTD2026-08-07
B382SD902509010Surgical DirectSurgical Direct, Inc.HTD2026-08-07
00190776422844MillenniumAvalign Technologies, Inc.HTD2026-08-03
B382SD4121490Surgical DirectSurgical Direct, Inc.HTD2026-08-03
00190776422349MillenniumAvalign Technologies, Inc.HTD2026-07-31
00810143904567SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906158SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906349SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906356SURGIPROSSurgipros, LLCHTD2026-07-31
00810143906448SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931029SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931036SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931043SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931050SURGIPROSSurgipros, LLCHTD2026-07-31
00810212931913SURGIPROSSurgipros, LLCHTD2026-07-31
00810212934907SURGIPROSSurgipros, LLCHTD2026-07-31
00810212935133SURGIPROSSurgipros, LLCHTD2026-07-31
00810212935638SURGIPROSSurgipros, LLCHTD2026-07-31
B382S028531010Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S028531030Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S28531800Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382S8541010Surgical DirectSurgical Direct, Inc.HTD2026-07-31
B382SD1355500Surgical DirectSurgical Direct, Inc.HTD2026-07-31
00840277133724Innomed, Inc.INNOMED, INC.HTD2026-07-29
B382SD92022614E0Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9203561000Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B382SD9206011020Surgical DirectSurgical Direct, Inc.HTD2026-07-29
B3825SD918621130Surgical DirectSurgical Direct, Inc.HTD2026-07-28