FDA.reportPublic FDA data

LEOS

Primary DI
00196449001583
Brand
LEOS
Company
Tyber Medical, LLC
Model
7621-4060
Catalog number
7621-4060
Device description
LEOS 4.0mm Locking Screw, VA 60mm
Published
2022-10-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
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
K222465000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222465000Tyber Medical Anatomical Plating SystemTyber Medical, LLC2023-03-07HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449001583PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449001583001964490015831964490015830196449001583

GMDN Terms#

Term, Definition table
TermDefinition
Internal orthopaedic fixation system, plate/screw, non-bioabsorbable, non-sterileA non-sterile assembly of implantable devices designed for the stabilization of fractured/surgically-cut bones of the limbs (long bones), their appendages (hands, feet), pelvis, craniomaxillofacial bones, and/or for limb-joint fusion. It typically consists of a set of bone fixation plates, screws, wires, and pins made of materials that cannot be chemically degraded or absorbed via natural body processes (e.g., implant grade metal, surgical steel, titanium alloy, or carbon fibre). It may also include instruments for the attachment of the implants such as screwdrivers or drills. This device is intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method

Contacts#

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

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
00196449001774LEOS7624-32087624-32082022-10-04
00196449010219A.L.P.S. mvX™7700240107700240102023-12-15
00196449012800A.L.P.S. mvX™7700240207700240202023-12-15
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810112592245TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592252TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592429TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592450TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592474TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592634TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592832TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592849TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-23
00810112592986TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593006TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593013TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593020TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593037TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593044TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593051TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593068TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593075TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593082TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593099TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593105TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593112TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593129TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593136TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593143TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593150TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593167TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593174TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593181TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22
00810112593198TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHWC2024-02-22