FDA.reportPublic FDA data

ACUMED

Primary DI
10806378126017
Brand
ACUMED
Company
Acumed LLC
Model
3070-27010
Device description
2.7mm x 10mm T8 NL Screw, CoCr
Published
2025-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWCScrew, fixation, bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K251132000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K251132000The Acumed Wrist Fixation System - Plates; The Acumed Wrist Fixation System - ScrewsAcumed, LLC2025-07-14HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806378126017PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080637812601710806378126017

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended for internal orthopaedic fixation by being screwed into a limb bone, rib, the sternum and/or pelvis to hold a plate, nail, rod or prosthesis to the bone, or to provide direct interfragmentary stabilization of a fractured bone; it is not intended to be introduced through the sleeve of a femoral neck fixation plate/sleeve, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

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
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
10806378125997ACUMED3070-270082025-12-08
10806378126000ACUMED3070-270092025-12-08
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
10806378067426ACUMEDFX-4004-S2015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842078100004HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100011HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100028HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
00842078100035HammerFiXEXTREMITY MEDICAL, LLCHWC2026-10-29
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20810152101449DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
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20810152101463DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
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20810152101630DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101647DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101654DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13
20810152101661DYNAMIS™ Implant SystemPromethean Restorative, Inc.HWC2025-06-13