FDA.reportPublic FDA data

Washers

Primary DI
00842188109218
Brand
Washers
Company
Trimed, INC.
Model
AFSW
Catalog number
AFSW
Device description
Ankle Fixation System Washer
Published
2016-09-07
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
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
NDGWASHER, BOLT, NUT, NON-SPINAL, METALLIC

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NDGWasher, Bolt, Nut, Non-Spinal, MetallicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243999000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243999000TriMed Ankle Fixation SystemTriMed, Inc.2025-03-19HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188109218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188109218008421881092188421881092180842188109218

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.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(661)255-7406info@trimedortho.com

Regulatory Flags#

DUNS number
138041277
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
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
00842188100864Locking PlatesPS12PS122016-09-07
00842188100871Locking PlatesPS15PS152016-09-07
00842188100895Hook PlatesHOOK-4HOOK-42016-09-07
00842188100901Hook PlatesHOOK-6HOOK-62016-09-07
00842188100918Hook PlatesHOOK-8HOOK-82016-09-07
00842188100925Hook PlatesHOOK-10HOOK-102016-09-07
00842188100932Hook PlatesHOOK-12HOOK-122016-09-07
00842188101366SideWinder Fracture PlatesSWOL-6MSWOL-6M2016-09-07
00842188101373SideWinder Fracture PlatesSWOL-6NSWOL-6N2016-09-07
00842188101380SideWinder Fracture PlatesSWOL-6WSWOL-6W2016-09-07
00842188101397SideWinder Fracture PlatesSWOL-7MSWOL-7M2016-09-07
00842188101403SideWinder Fracture PlatesSWOL-7NSWOL-7N2016-09-07
00842188101410SideWinder Fracture PlatesSWOL-7WSWOL-7W2016-09-07
00842188101427SideWinder Fracture PlatesSWOR-6MSWOR-6M2016-09-07
00842188101434SideWinder Fracture PlatesSWOR-6NSWOR-6N2016-09-07
00842188101441SideWinder Fracture PlatesSWOR-6WSWOR-6W2016-09-07
00842188101458SideWinder Fracture PlatesSWOR-7MSWOR-7M2016-09-07
00842188101465SideWinder Fracture PlatesSWOR-7NSWOR-7N2016-09-07
00842188101472SideWinder Fracture PlatesSWOR-7WSWOR-7W2016-09-07
00842188101489Locking PlatesSMTP-3SMTP-32016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197998470431Solventum™ Bair Hugger™Solventum US LLCNDG2026-04-29
00197998470455Solventum™ Bair Hugger™Solventum US LLCNDG2026-04-29
08800089451005Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2024-09-25
08800089446643ARIX System Bone ScrewJeil Medical CorporationNDG2024-03-19
00842188125362WashersTrimed, INC.NDG2023-01-05
05055662967555Volition Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2022-05-25
00810028392106Arsenal FootTrilliant Surgical, LLCNDG2022-05-02
00810028392113Arsenal FootTrilliant Surgical, LLCNDG2022-05-02
00810028392120TigerTrilliant Surgical, LLCNDG2022-05-02
08800089420391INLET System Bone ScrewJeil Medical CorporationNDG2021-11-19
08800089420407INLET System Bone ScrewJeil Medical CorporationNDG2021-11-19
05055662964844Volition™ Plating SystemORTHO SOLUTIONS HOLDINGS LIMITEDNDG2021-06-25
00885556784006EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784013EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784020EVOSSmith & Nephew, Inc.NDG2021-05-11
00885556784037EVOSSmith & Nephew, Inc.NDG2021-05-11
20885556746022SMART TSFSmith & Nephew, Inc.NDG2020-11-03
00885556746028SMART TSFSmith & Nephew, Inc.NDG2020-11-03
00885556746035SMART TSFSmith & Nephew, Inc.NDG2020-11-03
08806390891912Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390891929Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390891936Prometheus System Bone ScrewJeil Medical CorporationNDG2020-09-01
08806390858014VERUM System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390858021VERUM System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390865821Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390865838Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-03-20
08806390883641Summa Orthopaedics System Bone ScrewJeil Medical CorporationNDG2020-02-18
08806390850742ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08806390862288ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12
08809282815508ARIX System Bone ScrewJeil Medical CorporationNDG2019-12-12