FDA.reportPublic FDA data

N/A

Primary DI
M695M1154080
Brand
N/A
Company
Tyber Medical, LLC
Model
M1-15408
Published
2019-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

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
K133842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133842000TYBER MEDICAL TRAUMA SCREWTyber Medical, LLC2014-03-20HWC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M695M1154080PrimaryHIBCC0

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
010968002
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196449017348A.L.P.S. mvX™770001151A2026-06-04
00196449017355A.L.P.S. mvX™770002250A2026-06-04
00196449017362A.L.P.S. mvX™770002251A2026-06-04
00196449017379A.L.P.S. mvX™770001060A2026-06-04
00196449017386A.L.P.S. mvX™770001080A2026-06-04
00196449017393A.L.P.S. mvX™770001150A2026-06-04
00196449017409A.L.P.S. mvX™770002151A2026-06-04
00196449017416A.L.P.S. mvX™770002181A2026-06-04
00196449017423A.L.P.S. mvX™770002182A2026-06-04
00196449017430A.L.P.S. mvX™770002200A2026-06-04
00196449017447A.L.P.S. mvX™770002201A2026-06-04
00196449017454A.L.P.S. mvX™770001040A2026-06-04
00196449017461A.L.P.S. mvX™770002090A2026-06-04
00196449017478A.L.P.S. mvX™770002100A2026-06-04
00196449017485A.L.P.S. mvX™770002150A2026-06-04
00196449017492A.L.P.S. mvX™770002180A2026-06-04
00196449017508A.L.P.S. mvX™770003200A2026-06-04
00196449017515A.L.P.S. mvX™770003240A2026-06-04
00196449017522A.L.P.S. mvX™770003270A2026-06-04
00196449017539A.L.P.S. mvX™770003350A2026-06-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700569658212Xpert PFPNEWCLIP TECHNICSHWC2026-06-03
00842188131981CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188131998CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132001CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132018CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132025CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132032CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132049CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132056CannCompScrew 2.0mm (SelfDrill)Trimed, INC.HWC2026-06-02
00842188132063Tools - HCSTrimed, INC.HWC2026-06-02
00842188132070Tools - HCSTrimed, INC.HWC2026-06-02
07630894829819APTUSMedartis AGHWC2026-06-01
07630894829826APTUSMedartis AGHWC2026-06-01
07630894829833APTUSMedartis AGHWC2026-06-01
07630894829840APTUSMedartis AGHWC2026-06-01
07630894829857APTUSMedartis AGHWC2026-06-01
07630894829864APTUSMedartis AGHWC2026-06-01
07630894829871APTUSMedartis AGHWC2026-06-01
07630894829888APTUSMedartis AGHWC2026-06-01
07630894829895APTUSMedartis AGHWC2026-06-01
07630894829901APTUSMedartis AGHWC2026-06-01
07630894829918APTUSMedartis AGHWC2026-06-01
07630894829925APTUSMedartis AGHWC2026-06-01
07630894829932APTUSMedartis AGHWC2026-06-01
07630894829949APTUSMedartis AGHWC2026-06-01
07630894829956APTUSMedartis AGHWC2026-06-01
07630894829963APTUSMedartis AGHWC2026-06-01
07630894829970APTUSMedartis AGHWC2026-06-01
07630894829987APTUSMedartis AGHWC2026-06-01
07630894829994APTUSMedartis AGHWC2026-06-01