FDA.reportPublic FDA data

Tyber Medical

Primary DI
M695409452751A
Brand
Tyber Medical
Company
Tyber Medical, LLC
Model
Headed Cannulated Screw Short Ø4.5mm x 75mm
Catalog number
409-45275
Published
2018-02-02
Public version status
Update
Distribution status
Not 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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M695409452751APrimaryHIBCC0

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

Regulatory Flags#

DUNS number
010968002
Device count
1
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
00196449017645Anatomic Access LLIF818000362026-06-23
00196449035373Anatomic Access LLIF818000132026-06-23
00196449010134Anatomic Access LLIF818000292026-06-09
00196449010196Anatomic Access LLIF818000342026-06-09
00196449010288Anatomic Access LLIF818000352026-06-09
00196449035243Anatomic Access LLIF818000002026-06-09
00196449035250Anatomic Access LLIF818000012026-06-09
00196449035267Anatomic Access LLIF818000022026-06-09
00196449035281Anatomic Access LLIF818000042026-06-09
00196449035298Anatomic Access LLIF818000052026-06-09
00196449035304Anatomic Access LLIF818000062026-06-09
00196449035311Anatomic Access LLIF818000072026-06-09
00196449035328Anatomic Access LLIF818000082026-06-09
00196449035335Anatomic Access LLIF818000092026-06-09
00196449035366Anatomic Access LLIF818000122026-06-09
00196449035380Anatomic Access LLIF818000142026-06-09
00196449035397Anatomic Access LLIF818000152026-06-09
00196449035441Anatomic Access LLIF818000202026-06-09
00196449035465Anatomic Access LLIF818000222026-06-09
00196449035472Anatomic Access LLIF818000232026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055662970890ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWC2026-07-10
05055662971514ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWC2026-07-10
00885556904879EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556904923EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906163EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906170EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906187EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906194EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906200EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906217EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906224EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906231EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906248EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906255EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906262EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906279EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906286EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906293EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906309EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906316EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556906323EVOSSmith & Nephew, Inc.HWC2026-06-25
00885556901946EVOSSmith & Nephew, Inc.HWC2026-06-24
00888867460973Arthrex®ARTHREX, INC.HWC2026-06-11
00193982586393CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586416CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586430CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586454CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586478CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586690CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10
00193982586706CAPTIVATEGLOBUS MEDICAL, INC.HWC2026-06-10