FDA.reportPublic FDA data

LEOS Cannulated Screw System

Primary DI
00196449002696
Brand
LEOS Cannulated Screw System
Company
Tyber Medical, LLC
Model
76312520
Catalog number
76312520
Device description
LEOS 2.5 X 20mm HD Cann Screw, Ti
Published
2023-12-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449002696PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449002696001964490026961964490026960196449002696

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone screw (non-sliding)A small, threaded, non-bioabsorbable, implantable rod intended 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, not used in dentistry/orthodontics, craniofacial or spinal bones, and not dedicated to intramedullary fixation/arthrodesis. It is typically of cortical or cancellous design and has a drive (e.g., slot, cross, star, polygonal) at its proximal end for introduction with a screwdriver.

Contacts#

Phone, Email table
PhoneEmail
+1(866)761-0933preese@tybermed.com

Regulatory Flags#

DUNS number
010968002
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
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196449002511LEOS Cannulated Screw System76312008763120082023-12-08
00196449002528LEOS Cannulated Screw System76312010763120102023-12-08
00196449002535LEOS Cannulated Screw System76312012763120122023-12-08
00196449002542LEOS Cannulated Screw System76312014763120142023-12-08
00196449002559LEOS Cannulated Screw System76312016763120162023-12-08
00196449002566LEOS Cannulated Screw System76312018763120182023-12-08
00196449002573LEOS Cannulated Screw System76312020763120202023-12-08
00196449002580LEOS Cannulated Screw System76312022763120222023-12-08
00196449002597LEOS Cannulated Screw System76312024763120242023-12-08
00196449002603LEOS Cannulated Screw System76312026763120262023-12-08
00196449002610LEOS Cannulated Screw System76312028763120282023-12-08
00196449002627LEOS Cannulated Screw System76312030763120302023-12-08
00196449002634LEOS Cannulated Screw System76312508763125082023-12-08
00196449002641LEOS Cannulated Screw System76312510763125102023-12-08
00196449002658LEOS Cannulated Screw System76312512763125122023-12-08
00196449002665LEOS Cannulated Screw System76312514763125142023-12-08
00196449002672LEOS Cannulated Screw System76312516763125162023-12-08
00196449002689LEOS Cannulated Screw System76312518763125182023-12-08
00196449002702LEOS Cannulated Screw System76312522763125222023-12-08
00196449002719LEOS Cannulated Screw System76312524763125242023-12-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07901125621176Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-09-18
07901125621183Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-09-18
07901125621190Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-09-18
07901125621206Versalock Mini and Micro Plating SystemGM DOS REIS INDUSTRIA E COMERCIO LTDAHWC2026-09-18
00885556838303Total Foot System 2Smith & Nephew, Inc.HWC2023-04-25
00885556838327Total Foot System 2Smith & Nephew, Inc.HWC2023-04-18
00885556824764DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824771DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824788DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824795DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824818DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556824825DigiFuse Cannulated Intramedullary FusionSmith & Nephew, Inc.HWC2023-02-10
00885556835043Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835050Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835081Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835098Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835111Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835128Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835135Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835142Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835159Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556835173Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836187Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836484Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836163Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836170Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836194Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836200Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836217Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22
00885556836392Ti6 Internal Fixation SystemSmith & Nephew, Inc.HWC2022-12-22