FDA.reportPublic FDA data

Tools - FPS

Primary DI
00842188121234
Brand
Tools - FPS
Company
Trimed, INC.
Model
FPS-HINDFOOT
Catalog number
FPS-HINDFOOT
Device description
ASET Foot Plating System Hindfoot Caddy
Published
2020-01-21
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
FSMTRAY, SURGICAL, INSTRUMENT

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FSMTray, Surgical, InstrumentGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192696000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192696000TriMed ASET Foot Plating SystemTriMed, Inc.2020-01-05HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00842188121234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00842188121234008421881212348421881212340842188121234

GMDN Terms#

Term, Definition table
TermDefinition
Instrument trayA container intended to provide a suitable platform for containing many medical/surgical instruments and related items during a clinical procedure; it might in addition be used during reprocessing/sterilization procedures, however it is not dedicated to reprocessing/sterilization. It is typically designed as a shallow vessel with a raised rim, or as a deeper cassette-like device, and it might include a lid. It is designed to fit into other devices such as supply trolleys, storage systems and sterilizers. This is a reusable 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
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00842188132452Tools - TWFNSF-CADDY-LIDNSF-CADDY-LID2026-08-18
00842188127014Tools - FMSFMS-TRAY-LIDFMS-TRAY-LID2023-04-19
00842188100437Foot PlatesSP20-3SSP20-3S2016-09-07
00842188100444Foot PlatesSP20-3MSP20-3M2016-09-07
00842188100451Foot PlatesSP20-4SP20-42016-09-07
00842188100468Foot PlatesSP20-6SP20-62016-09-07
00842188100475Foot PlatesTP20-5TP20-52016-09-07
00842188100482Foot PlatesTP20-7TP20-72016-09-07
00842188100888Locking PlatesBRGPBRGP2016-09-07
00842188100949Hook PlatesMHOOK-5MHOOK-52016-09-07
00842188100956Hook PlatesMHOOK-7MHOOK-72016-09-07
00842188101526Osteotomy Compression PlatesUOCPUOCP2016-09-07
00842188101533Osteotomy Compression PlatesUOCP-SUOCP-S2016-09-07
00842188105425FPS Locking Screw 2.0mmCLS2.0-06CLS2.0-062016-09-07
00842188105432FPS Locking Screw 2.0mmCLS2.0-08CLS2.0-082016-09-07
00842188105449FPS Locking Screw 2.0mmCLS2.0-10CLS2.0-102016-09-07
00842188105456FPS Locking Screw 2.0mmCLS2.0-12CLS2.0-122016-09-07
00842188105463FPS Locking Screw 2.0mmCLS2.0-14CLS2.0-142016-09-07
00842188105470FPS Locking Screw 2.0mmCLS2.0-16CLS2.0-162016-09-07
00842188105487FPS Locking Screw 2.0mmCLS2.0-18CLS2.0-182016-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08800037575166ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575173ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037575180ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
08800037585110ANAX™ 5.5 SPINAL SYSTEMCG MedTech Co.,Ltd.FSM2026-09-04
07640221370884TRYPTIK® TiSpineArt SAFSM2026-08-27
07613327630602MakoMAKO SURGICAL CORP.FSM2026-08-25
00724995296216V. MuellerSteris CorporationFSM2026-08-21
00724995296223V. MuellerSteris CorporationFSM2026-08-21
00724995296230V. MuellerSteris CorporationFSM2026-08-21
00724995296247V. MuellerSteris CorporationFSM2026-08-21
00724995296254V. MuellerSteris CorporationFSM2026-08-21
00724995296261V. MuellerSteris CorporationFSM2026-08-21
00724995296278V. MuellerSteris CorporationFSM2026-08-21
00724995296285V. MuellerSteris CorporationFSM2026-08-21
00724995296292V. MuellerSteris CorporationFSM2026-08-21
00724995296308V. MuellerSteris CorporationFSM2026-08-21
00724995296315V. MuellerSteris CorporationFSM2026-08-21
00724995296322V. MuellerSteris CorporationFSM2026-08-21
00724995296339V. MuellerSteris CorporationFSM2026-08-21
00724995296346V. MuellerSteris CorporationFSM2026-08-21
00724995296353V. MuellerSteris CorporationFSM2026-08-21
00724995296360V. MuellerSteris CorporationFSM2026-08-21
00724995296377V. MuellerSteris CorporationFSM2026-08-21
00724995296384V. MuellerSteris CorporationFSM2026-08-21
00724995296391V. MuellerSteris CorporationFSM2026-08-21
00724995296407V. MuellerSteris CorporationFSM2026-08-21
00724995296414V. MuellerSteris CorporationFSM2026-08-21
00724995296421V. MuellerSteris CorporationFSM2026-08-21
00724995296438V. MuellerSteris CorporationFSM2026-08-21
00724995296445V. MuellerSteris CorporationFSM2026-08-21