FDA.reportPublic FDA data

LTJ

Primary DI
00810041623539
Brand
LTJ
Company
AzurMeds Inc.
Model
81004162353
Device description
LTJ 4.5mm Cannulated Ti Screw L. 32mm Non Sterile
Published
2021-05-01
Public version status
Update
Distribution status
Not 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
HWCScrew, Fixation, Bone

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210268000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210268000LTJ Screws and WasherAzurmeds, Inc.2021-02-26HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810041623539PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810041623539008100416235398100416235390810041623539

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
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
773 564 9324contact@azurmeds.us

Regulatory Flags#

DUNS number
117700483
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810041623300LTJ810041623302021-05-01
00810041623317LTJ810041623312021-05-01
00810041623324LTJ810041623322021-05-01
00810041623331LTJ810041623332021-05-01
00810041623348LTJ810041623342021-05-01
00810041623355LTJ810041623352021-05-01
00810041623362LTJ810041623362021-05-01
00810041623379LTJ810041623372021-05-01
00810041623409LTJ810041623402021-05-01
00810041623430LTJ810041623432021-05-01
00810041623508LTJ810041623502021-05-01
00810041623515LTJ810041623512021-05-01
00810041623522LTJ810041623522021-05-01
00810041623546LTJ810041623542021-05-01
00810041623553LTJ810041623552021-05-01
00810041623560LTJ810041623562021-05-01
00810041623577LTJ810041623572021-05-01
00810041623607LTJ810041623602021-05-01
00810041623638LTJ810041623632021-05-01
00810041621313LTJ810041621312020-10-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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03700569633967NANEWCLIP TECHNICSHWC2026-10-01
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03700569634001NANEWCLIP TECHNICSHWC2026-10-01
03700569634025NANEWCLIP TECHNICSHWC2026-10-01
03700569634049NANEWCLIP TECHNICSHWC2026-10-01
03700569634063NANEWCLIP TECHNICSHWC2026-10-01
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08057717550665BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
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08057717550788BRM TOOL Titanium ScrewBRM EXTREMITIES SRLHWC2026-09-30
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