FDA.reportPublic FDA data

Monster Screw System

Primary DI
00889795001146
Brand
Monster Screw System
Company
Paragon 28, Inc.
Model
P20-025-DW00
Catalog number
P20-025-DW00
Device description
2.5 Flat Washer, Mini Monster
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
HTNWASHER, BOLT NUT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HTNWasher, Bolt NutOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889795001146PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889795001146008897950011468897950011460889795001146

GMDN Terms#

Term, Definition table
TermDefinition
Implantable bone washerAn implantable, flat ring or plate designed to be used with a nut and bolt/screw to improve tightness in an orthopaedic, spinal, and/or craniofacial bone fixation assembly. It may be made of metal, polymer, or reinforced polymer. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
042961576
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889795118011Monkey Rings™ External Fixation SystemP45-511-0001P45-511-00012026-05-06
00889795152114Monkey Rings™ External Fixation SystemP45-113-0120P45-113-01202026-05-06
00889795152121Monkey Rings™ External Fixation SystemP45-113-0140P45-113-01402026-05-06
00889795152138Monkey Rings™ External Fixation SystemP45-113-0160P45-113-01602026-05-06
00889795152145Monkey Rings™ External Fixation SystemP45-113-0180P45-113-01802026-05-06
00889795152152Monkey Rings™ External Fixation SystemP45-113-0200P45-113-02002026-05-06
00889795152169Monkey Rings™ External Fixation SystemP45-113-0220P45-113-02202026-05-06
00889795152176Monkey Rings™ External Fixation SystemP45-191-4650P45-191-46502026-05-06
00889795152183Monkey Rings™ External Fixation SystemP45-191-5055P45-191-50552026-05-06
00889795152190Monkey Rings™ External Fixation SystemP45-191-5070P45-191-50702026-05-06
00889795152206Monkey Rings™ External Fixation SystemP45-191-6055P45-191-60552026-05-06
00889795152213Monkey Rings™ External Fixation SystemP45-191-6070P45-191-60702026-05-06
00889795152244Monkey Rings™ External Fixation SystemP45-196-4650P45-196-46502026-05-06
00889795152251Monkey Rings™ External Fixation SystemP45-196-5055P45-196-50552026-05-06
00889795152268Monkey Rings™ External Fixation SystemP45-196-5070P45-196-50702026-05-06
00889795152275Monkey Rings™ External Fixation SystemP45-196-6055P45-196-60552026-05-06
00889795152282Monkey Rings™ External Fixation SystemP45-196-6070P45-196-60702026-05-06
00889795152299Monkey Rings™ External Fixation SystemP45-197-2333P45-197-23332026-05-06
00889795152367Monkey Rings™ External Fixation SystemP45-334-1000P45-334-10002026-05-06
00889795152374Monkey Rings™ External Fixation SystemP45-334-1001P45-334-10012026-05-06

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00888867529045Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529052Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529106Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529120Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529168Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529199Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529205Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529229Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529236Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529243Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529281Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529328Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529335Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529410Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529427Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529472Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529519Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529540Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529557Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529588Arthrex®ARTHREX, INC.HTN2026-03-16
00888867529601Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530072Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530096Arthrex®ARTHREX, INC.HTN2026-03-16
00888867530195Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531895Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531949Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531970Arthrex®ARTHREX, INC.HTN2026-03-16
00888867531987Arthrex®ARTHREX, INC.HTN2026-03-16
00888867532014Arthrex®ARTHREX, INC.HTN2026-03-16
00888867532038Arthrex®ARTHREX, INC.HTN2026-03-16