FDA.reportPublic FDA data

ACUMED

Primary DI
10806378114922
Brand
ACUMED
Company
Acumed LLC
Model
3005-40022-S
Device description
4.0mm X 22mm Cann. Screw, Short Thread
Published
2022-09-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
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
K123890000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123890000ACUMED CANNULATED SCREW SYSTEMAcumed, LLC2013-03-18HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10806378114922PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1080637811492210806378114922

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw, non-bioabsorbable, non-sterileA small, non-sterile, threaded rod with a slotted head typically used for internal orthopaedic fracture fixation by being screwed into bone to hold plates or nails to bone or to provide direct interfragmentary stabilization of bone, or it may fasten soft tissue to bone; it is made of a material that cannot be chemically degraded or absorbed via natural body processes (includes implant grade metal such as surgical steel, titanium alloy, or carbon fibre). Screws available are: cortical, cancellous, malleolar, scaphoid, partially-threaded and fully-threaded, self-tapping, and cannulated. A "lag screw" can be any of these used to obtain compression. This device must be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
196884852
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
10806378124273ACUMED80-42452025-12-08
10806378124280ACUMED80-43232025-12-08
10806378124297ACUMED80-43222025-12-08
10806378124310ACUMED7006-3401N2025-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449002511LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002528LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002535LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002542LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002559LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002566LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002573LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002580LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002597LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002603LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002610LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002627LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002634LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002641LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002658LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002665LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002672LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002689LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002696LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002702LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002719LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002726LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002733LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002740LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002757LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002764LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002771LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002788LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002795LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08
00196449002801LEOS Cannulated Screw SystemTyber Medical, LLCHWC2023-12-08