FDA.reportPublic FDA data

LEOS Cannulated Screw System

Primary DI
00810040689314
Brand
LEOS Cannulated Screw System
Company
Tyber Medical LLC
Model
76308523
Catalog number
76308523
Device description
Countersink 2.0 Cann HD Screws
Published
2023-12-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
HWWCOUNTERSINK

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HWWCountersinkOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00810040689314PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810040689314008100406893148100406893140810040689314

GMDN Terms#

Term, Definition table
TermDefinition
Surgical countersink, reusableA rotary surgical instrument designed to enlarge the diameter of the proximal portion of a hole drilled in bone. It is a shaft of metal with a cutting head, available in various configurations, that is rotated at low speeds typically by a drilling system. The device is typically used to recess the head of a screw/bolt within bone (enable it to lie flush with or below the bone surface) or to help accommodate the implantation of a device in bone. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
010968002
Device count
1
DM exempt
false
Premarket exempt
true
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
00196449024803Cannulated Headless Screw - Full Thread04.345.008TS2025-07-19
00196449024834Cannulated Headless Screw - Full Thread04.345.009TS2025-07-19
00196449024865Cannulated Headless Screw - Full Thread04.345.010TS2025-07-19
00196449024896Cannulated Headless Screw - Full Thread04.345.011TS2025-07-19
00196449024926Cannulated Headless Screw - Full Thread04.345.012TS2025-07-19
00196449024957Cannulated Headless Screw - Full Thread04.345.013TS2025-07-19
00196449024988Cannulated Headless Screw - Full Thread04.345.014TS2025-07-19
00196449025015Cannulated Headless Screw - Full Thread04.345.015TS2025-07-19
00196449025046Cannulated Headless Screw - Full Thread04.345.016TS2025-07-19
00196449025077Cannulated Headless Screw - Full Thread04.345.017TS2025-07-19
00196449025107Cannulated Headless Screw - Full Thread04.345.018TS2025-07-19
00196449025138Cannulated Headless Screw - Full Thread04.345.019TS2025-07-19
00196449025169Cannulated Headless Screw - Full Thread04.345.020TS2025-07-19
00196449025190Cannulated Headless Screw - Full Thread04.345.022TS2025-07-19
00196449025220Cannulated Headless Screw - Full Thread04.345.024TS2025-07-19
00196449025251Cannulated Headless Screw - Full Thread04.345.026TS2025-07-19
00196449025282Cannulated Headless Screw - Full Thread04.345.028TS2025-07-19
00196449025312Cannulated Headless Screw - Full Thread04.345.030TS2025-07-19
00196449025343Cannulated Headless Screw - Full Thread04.345.032TS2025-07-19
00196449025374Cannulated Headless Screw - Full Thread04.345.034TS2025-07-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
05055662971576ORTHO SOLUTIONS SUCCESSION AFN SYSTEMORTHO SOLUTIONS HOLDINGS LIMITEDHWW2026-03-04
00194613014766MSI Precision Specialty InstrumentsMed Saver, Inc.HWW2025-08-01
00885556896464TRIGEN MAXSmith & Nephew, Inc.HWW2025-05-07
04042409452741NAaap Implantate AGHWW2025-02-26
04042409452789NAaap Implantate AGHWW2025-02-26
04042409452826NAaap Implantate AGHWW2025-02-26
04042409452864NAaap Implantate AGHWW2025-02-26
10888277373754MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277379152MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
10888277390072MEDLINEMEDLINE INDUSTRIES, INC.HWW2025-02-21
00810074306232Small Cannulated Countersink AO 125mmOsteocentric Technologies, Inc.HWW2024-12-06
00810111223416Depth gauge countersinkTreace Medical Concepts, Inc.HWW2024-11-19
04048266076830N/AMerete GmbHHWW2024-10-18
07612334236654NASynthes GmbHHWW2024-10-09
08800089451128Summa Orthopaedics System Surgical InstrumentJeil Medical CorporationHWW2024-09-25
00889795137098Phantom® Fibula Nail SystemPARAGON 28, INC.HWW2024-09-24
B504OM45300070StrykerProvisionHWW2024-08-26
B504OMAR8943050ArthrexProvisionHWW2024-08-13
B504OM127000040Extremity MedicalProvisionHWW2024-08-12
008100283950772.0/2.4 CountersinkTrilliant Surgical, LLCHWW2024-06-07
008100283950843.0/4.0 CountersinkTrilliant Surgical, LLCHWW2024-06-07
B504OM3108900SynthesProvisionHWW2024-05-17
B504OMP06N07110In2BonesProvisionHWW2024-05-17
B504OMP2091030000Paragon 28ProvisionHWW2024-05-17
B504OMA39370MedartisProvisionHWW2024-05-13
B504OMA39380MedartisProvisionHWW2024-05-13
B504OM3109710SynthesProvisionHWW2024-05-06
05055662969818COGNiTiON™ Staple SystemORTHO SOLUTIONS HOLDINGS LIMITEDHWW2024-04-01
B504OMHSINK350TriMedProvisionHWW2024-03-28
08800089445516Surgical InstrumentJeil Medical CorporationHWW2024-03-19