FDA.reportPublic FDA data

ACUMED

Primary DI
10806378027758
Brand
ACUMED
Company
Acumed LLC
Model
3701-2017N
Device description
Ratcheting Compression Plate 20X17
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
JDRSTAPLE, FIXATION, BONE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806378027758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080637802775810806378027758

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

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
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
00888867574342Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574359Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574366Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574373Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574380Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574397Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574403Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574410Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574427Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574434Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574441Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574458Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574465Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574595Arthrex®ARTHREX, INC.JDR2026-09-18
00888867574601Arthrex®ARTHREX, INC.JDR2026-09-18
00811714036472ThunderboltRESPONSIVE ORTHOPEDICS LLCJDR2026-07-31
00811714036489ThunderboltRESPONSIVE ORTHOPEDICS LLCJDR2026-07-31
00810135964180VertexNVision Biomedical Technologies, Inc.JDR2025-12-17
00860005968824RELJA Innovations Nitinol Staple Kit 15mmx12mmRelja Innovations LLCJDR2025-09-19
00860005968831RELJA Innovations Nitinol Staple Kit 18x18Relja Innovations LLCJDR2025-09-19
10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
07630037889397APTUSMedartis AGJDR2023-03-03
00810005661010VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661027VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661034VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661041VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661058VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661065VertexNVision Biomedical Technologies, Inc.JDR2020-12-28
00810005661072VertexNVision Biomedical Technologies, Inc.JDR2020-12-28