FDA.reportPublic FDA data

A.L.P.S. mvX™

Primary DI
00196449033386
Brand
A.L.P.S. mvX™
Company
Tyber Medical, LLC
Model
770107060
Device description
ANKLE SCREW RACK LID B
Published
2025-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HRSPlate, fixation, bone
HWCScrew, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
HWCScrew, Fixation, BoneOrthopedic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449033386PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449033386001964490333861964490333860196449033386

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument/implant rackA device designed as a small case, typically with a hinged lid that can be closed to protect the contents (i.e., surgical instruments and/or implantable devices such as plates or screws), and an integral rest(s) with grooves or notches in the upper edge so that the contents can be securely placed, protected, and organized. The lid or rest may be set at an angle to facilitate instrument/implant access during surgical procedures or sterilization. The device is typically be made of stainless steel or a suitable plastic material so that it can be sterilized. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
010968002
Device count
1
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00196449033393A.L.P.S. mvX™7701030902026-07-23
00196449033409A.L.P.S. mvX™7701070902026-07-23
00196449011735A.L.P.S. mvX™7703000407703000402024-01-20
00196449011742A.L.P.S. mvX™7703000457703000452024-01-20
00196449011759A.L.P.S. mvX™7703000507703000502024-01-20
00196449011766A.L.P.S. mvX™7703000557703000552024-01-20
00196449011773A.L.P.S. mvX™7703000607703000602024-01-20
00196449011780A.L.P.S. mvX™7703000707703000702024-01-20
00196449011797A.L.P.S. mvX™7703520407703520402024-01-20
00196449011803A.L.P.S. mvX™7703520457703520452024-01-20
00196449011810A.L.P.S. mvX™7703520507703520502024-01-20
00196449011827A.L.P.S. mvX™7703520557703520552024-01-20
00196449011834A.L.P.S. mvX™7703520607703520602024-01-20
00196449011841A.L.P.S. mvX™7703520707703520702024-01-20
00196449011858A.L.P.S. mvX™7704010407704010402024-01-20
00196449011865A.L.P.S. mvX™7704010457704010452024-01-20
00196449011872A.L.P.S. mvX™7704010507704010502024-01-20
00196449011889A.L.P.S. mvX™7704010557704010552024-01-20
00196449011896A.L.P.S. mvX™7704010607704010602024-01-20
00196449011902A.L.P.S. mvX™7704010707704010702024-01-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00196449033393A.L.P.S. mvX™Tyber Medical, LLCHWC2026-07-23
00196449033409A.L.P.S. mvX™Tyber Medical, LLCHWC2026-07-23
00888233028875Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028882Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028899Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086110Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086127Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086134Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086141Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086158Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086165Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086172Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086189Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086196Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086202Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086219Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00841731140395ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140401ARTEMIS FUZEVILEX LLCHWC2026-07-22
00841731140418ARTEMIS FUZEVILEX LLCHWC2026-07-22
00196449011735A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011742A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011759A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011766A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011773A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011780A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011797A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011803A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011810A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011827A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20
00196449011834A.L.P.S. mvX™Tyber Medical, LLCHWC2024-01-20