FDA.reportPublic FDA data

A.L.P.S. mvX™

Primary DI
00196449010165
Brand
A.L.P.S. mvX™
Company
Tyber Medical, LLC
Model
770020010
Catalog number
770020010
Device description
PLATE CUTTING PLIERS
Published
2023-12-15
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
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449010165PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449010165001964490101651964490101650196449010165

GMDN Terms#

Term, Definition table
TermDefinition
Bone fixation plate pliersA manual surgical instrument designed to bend and cut light-bone fixation plates (e.g., 1 to 2 mm in thickness), such as those used in craniomaxillofacial (CMF) or finger surgery. The instrument is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot to form jaws that bend and cut the metal plates allowing the surgeon to customize their size and shape. 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
Premarket exempt
true
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
00763000880118MSB Reusable InstrumentsMEDTRONIC SOFAMOR DANEK, INC.LXH2026-10-23
00842528130056OSTEOMEDOSTEOMED LLCLXH2026-10-23
00888867550391Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550407Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550414Arthrex®ARTHREX, INC.LXH2026-10-23
00888867550421Arthrex®ARTHREX, INC.LXH2026-10-23
04251631412144BEE PLIFNGMedical GmbHLXH2026-10-23
M739153997700Cross Connector DriverCAPTIVA SPINE, INC.LXH2026-10-23
M739153998800Cross Connector Counter TorqueCAPTIVA SPINE, INC.LXH2026-10-23
M739243501000Blade DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243502000Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243503000In-Line HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739243504000Tissue DilatorCAPTIVA SPINE, INC.LXH2026-10-23
M739243505000Tissue ProtectorCAPTIVA SPINE, INC.LXH2026-10-23
M739243506000Adjustable Parallel GuideCAPTIVA SPINE, INC.LXH2026-10-23
M739243507000Impaction SleeveCAPTIVA SPINE, INC.LXH2026-10-23
M739243508000Self-Feeding DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739243509000Implant Filling TubeCAPTIVA SPINE, INC.LXH2026-10-23
M739243511000Plunger RodCAPTIVA SPINE, INC.LXH2026-10-23
M739243512000Cannulated Drill, 7mmCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151066mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151077mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151088mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M7399830151099mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511010mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511111mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M73998301511212mm Cannulated DrillCAPTIVA SPINE, INC.LXH2026-10-23
M739983101200Coupling - Square ConnectCAPTIVA SPINE, INC.LXH2026-10-23
M739983240300Impaction T-HandleCAPTIVA SPINE, INC.LXH2026-10-23
M739985202530Marking PinCAPTIVA SPINE, INC.LXH2026-10-23