FDA.reportPublic FDA data

Arsenal Ankle

Primary DI
00810028391710
Brand
Arsenal Ankle
Company
Trilliant Surgical, LLC
Model
211-40-002
Device description
4.0mm Cannulated Countersink
Published
2022-05-02
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
HWWCountersink

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810028391710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810028391710008100283917108100283917100810028391710

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
828829072
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
00812926021461Arsenal Ankle210-40-0042017-03-15
00190446898757Arsenal Foot330-27-0032025-07-01
00190446898764Arsenal Foot330-27-0132025-07-01
00190446898771Arsenal Foot330-35-0132025-07-01
00810028395152Arsenal Ankle211-00-0082024-03-21
00810028391666Arsenal Ankle340-15-0032022-05-02
00810028391697Arsenal Ankle340-15-0072022-05-02
00810028391703Arsenal Ankle211-40-0012022-05-02
00810028391758Arsenal Ankle211-40-0042022-05-02
00810028391925Arsenal Ankle307-27-0422022-05-02
00810028391932Arsenal Ankle307-27-0442022-05-02
00810028391949Arsenal Ankle307-27-0462022-05-02
00810028391956Arsenal Ankle307-27-0482022-05-02
00810028391963Arsenal Ankle307-27-0502022-05-02
00810028391970Arsenal Ankle307-35-0552022-05-02
00810028391987Arsenal Ankle307-35-0602022-05-02
00810028391994Arsenal Ankle307-35-0652022-05-02
00810028392007Arsenal Ankle307-35-0702022-05-02
00810028392014Arsenal Ankle308-27-0422022-05-02
00810028392021Arsenal Ankle308-27-0442022-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
008890247128986.5/8.0mm Countersink, Cannulated ZH QCZimmer, Inc.HWW2026-08-25
00841731153081ARTEMIS FUZEVILEX LLCHWW2026-07-22
00841731153098ARTEMIS FUZEVILEX LLCHWW2026-07-22
00196449017591A.L.P.S. mvX™Tyber Medical, LLCHWW2026-06-04
00196449017607A.L.P.S. mvX™Tyber Medical, LLCHWW2026-06-04
00196449017614A.L.P.S. mvX™Tyber Medical, LLCHWW2026-06-04
00841731146854TITANEX VILEX LLCHWW2026-05-15
00841731146878TITANEX VILEX LLCHWW2026-05-15
00841731146892TITANEX VILEX LLCHWW2026-05-15
00841731146915TITANEX VILEX LLCHWW2026-05-15
00841731146939TITANEX VILEX LLCHWW2026-05-15
03700569679170Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
03700569679187Newclip InstrumentsNEWCLIP TECHNICSHWW2026-05-05
00810211043945Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043952Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043969Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043976Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043983Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211043990Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044003Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
00810211044010Ultra Compression Screw SystemPace Surgical, Inc.HWW2026-04-27
08437019739430WasherCap™ Countersink 11 mmABANZA TECNOMED SL.HWW2026-03-30
00810111225281Instrument TrayTreace Medical Concepts, Inc.HWW2026-03-30
05055662971576ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWW2026-03-04
00841731135308Redemption VILEX LLCHWW2026-01-12
00840118126250Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00840118126267Active CompressionFLOWER ORTHOPEDICS CORPORATIONHWW2025-11-21
00889795141330Phantom Hindfoot TTC/TC Nail SystemParagon 28, Inc.HWW2025-11-19
00194613014766MSI Precision Specialty InstrumentsMed Saver, Inc.HWW2025-08-01
00885556896464TRIGEN MAXSmith & Nephew, Inc.HWW2025-05-07