FDA.report

ACUMED

Primary DI
10806378055331
Brand
ACUMED
Company
Acumed LLC
Model
AP-0065
Device description
65.0mm Acutrak® Plus Fixation Screw
Published
2015-10-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Contact Domains

Product Codes

CodeName
HWCScrew, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10806378055331PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalized
1080637805533110806378055331

GMDN Terms

TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended to be used 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, or used in dentistry/orthodontics, craniofacial or spinal bones. It is typically of cortical or cancellous design and has a drive (e.g., a slot, or of cross, star, or polygonal shape) at its proximal end for introduction with a screwdriver. It is made of non-bioabsorbable materials (e.g., metal).

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

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
false
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

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10806378124310ACUMED7006-3401N2025-12-08
10806378124327ACUMED7006-3402L2025-12-08
10806378124334ACUMED7006-3402R2025-12-08
10806378124341ACUMED7006-3403L2025-12-08
10806378124358ACUMED7006-3403R2025-12-08
10806378124365ACUMED3073-000002025-12-08
10806378124372ACUMED7006-3301N2025-12-08
10806378124389ACUMED7006-3302N2025-12-08
10806378124662ACUMED7006-3201L2025-12-08
10806378124679ACUMED7006-3201R2025-12-08
10806378124686ACUMED7006-3202L2025-12-08

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