FDA.reportPublic FDA data

ACUMED

Primary DI
10806378097683
Brand
ACUMED
Company
Acumed LLC
Model
80-2448
Device description
FFN Base Plate
Published
2015-10-24
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
OJHOrthopedic tray

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OJHOrthopedic TrayGeneral, Plastic Surgery1

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K143276000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K143276000Acumed Small Bone IM Nail SystemAcumed, LLC2015-02-05HSB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806378097683PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080637809768310806378097683

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
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10806378067426ACUMEDFX-4004-S2015-10-24
10806378067594ACUMEDFX-4054-S2015-10-24
10806378040368ACUMED80-01802015-10-24
10806378099182ACUMED4014-0600-S2023-01-08
10806378116094ACUMED80-39662023-01-08
10806378116131ACUMED4014-0705-S2023-01-08
10806378116148ACUMED4014-0710-S2023-01-08
10806378116155ACUMED4014-0715-S2023-01-08
10806378099175ACUMED4014-06002024-12-18
10806378116971ACUMED4014-07052024-12-18
10806378116988ACUMED4014-07102024-12-18
10806378116995ACUMED4014-07152024-12-18
10806378105296ACUMED80-34522020-03-22
10806378111976ACUMED80-36582019-08-12

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B098AMS199160Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS199340Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS199930Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS6160F0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS9487F0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
B098AMS9509E0Aligned Medical SolutionsAligned Medical SolutionsOJH2026-09-26
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10198956424654CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956486645CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956500730CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956512016CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956519275CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956524033CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956541504CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956541603CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956545151CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
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10198956550575CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
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10198956556492CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
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10198956558960CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956559646CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956560079CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956560598CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25
10198956561212CARDINAL HEALTHCardinal Health 200, LLCOJH2026-09-25