FDA.reportPublic FDA data

ACUMED

Primary DI
10806378051173
Brand
ACUMED
Company
Acumed LLC
Model
80-1727
Device description
ARH Head Removal Tool Fork Assy
Published
2015-10-24
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWIPROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWIProsthesis, Elbow, Hemi-, Radial, PolymerOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K041858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K041858000ACUMED ANATOMIC RADIAL HEAD SYSTEMAcumed, LLC2004-10-05KWI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806378051173PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080637805117310806378051173

GMDN Terms#

Term, Definition table
TermDefinition
General internal orthopaedic fixation system implantation kitA collection of instruments and devices intended to be used for the placement of an internal orthopaedic fixation system into or onto all types of bones (e.g., bones of limbs, spine, pelvis, or craniomaxillofacial). It is a non-dedicated device that includes various metallic and/or plastic reusable devices [e.g., retractors, rods, clamps, drills, pins, saws, screwdrivers, guides, trials, impactors] intended to be used for the implantation of any type of internal orthopaedic fixation system; the implant(s) is not included. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(888)627-9957businessservices@acumed.net

Regulatory Flags#

DUNS number
196884852
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10806378125997ACUMED3070-270082025-12-08
10806378126000ACUMED3070-270092025-12-08
10806378126017ACUMED3070-270102025-12-08
10806378126024ACUMED3070-270112025-12-08
10806378126031ACUMED3070-270122025-12-08
10806378126048ACUMED3070-270132025-12-08
10806378126055ACUMED3070-270142025-12-08
10806378126062ACUMED3070-270152025-12-08
10806378126079ACUMED3070-270162025-12-08
10806378126086ACUMED3070-270172025-12-08
10806378126093ACUMED3070-270182025-12-08
10806378126109ACUMED3076-300102025-12-08
10806378126116ACUMED3076-300122025-12-08
10806378126123ACUMED3076-300142025-12-08
10806378116810ACUMED80-40572026-08-18
10806378116827ACUMED80-40582026-08-18
10806378116841ACUMED80-40602026-08-18
10806378116858ACUMED80-40612026-08-18
10806378067341ACUMEDFX-4000-S2015-10-24
10806378067372ACUMEDFX-4001-S2015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630894827495AVENGERMedartis AGKWI2026-10-21
07630894827501AVENGERMedartis AGKWI2026-10-21
07630894827518AVENGERMedartis AGKWI2026-10-21
07630894827525AVENGERMedartis AGKWI2026-10-21
07630894827532AVENGERMedartis AGKWI2026-10-21
07630894827549AVENGERMedartis AGKWI2026-10-21
07630894827556AVENGERMedartis AGKWI2026-10-21
07630894827563AVENGERMedartis AGKWI2026-10-21
07630894827570AVENGERMedartis AGKWI2026-10-21
07630894827587AVENGERMedartis AGKWI2026-10-21
07630894827594AVENGERMedartis AGKWI2026-10-21
07630894827600AVENGERMedartis AGKWI2026-10-21
07630894827617AVENGERMedartis AGKWI2026-10-21
07630894827624AVENGERMedartis AGKWI2026-10-21
07630894827631AVENGERMedartis AGKWI2026-10-21
07630894827648AVENGERMedartis AGKWI2026-10-21
07630894827655AVENGERMedartis AGKWI2026-10-21
07630894827662AVENGERMedartis AGKWI2026-10-21
07630894827679AVENGERMedartis AGKWI2026-10-21
07630894827686AVENGERMedartis AGKWI2026-10-21
07630894827693AVENGERMedartis AGKWI2026-10-21
07630894827709AVENGERMedartis AGKWI2026-10-21
00885556830543PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00885556830550PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00885556830567PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00885556830574PyroCarbon Modular Radial HeadSmith & Nephew, Inc.KWI2026-09-24
00888867570764Arthrex®ARTHREX, INC.KWI2026-09-21
00888867570771Arthrex®ARTHREX, INC.KWI2026-09-21
00888867568044Arthrex®ARTHREX, INC.KWI2026-09-17
00888867568051Arthrex®ARTHREX, INC.KWI2026-09-17