FDA.reportPublic FDA data

A.L.P.S. mvX™

Primary DI
00196449015474
Brand
A.L.P.S. mvX™
Company
Tyber Medical, LLC
Model
770013020
Catalog number
770013020
Device description
FIBULA HOOK PLATE DRILL GUIDE
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
HRSPlate, fixation, bone
LXHOrthopedic manual surgical instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2
LXHOrthopedic Manual Surgical InstrumentOrthopedic1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00196449015474PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00196449015474001964490154741964490154740196449015474

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(866)761-0933preese@tybermed.com
+1(866)761-0933ra@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
00196449017645Anatomic Access LLIF818000362026-06-23
00196449035373Anatomic Access LLIF818000132026-06-23
00196449010134Anatomic Access LLIF818000292026-06-09
00196449010196Anatomic Access LLIF818000342026-06-09
00196449010288Anatomic Access LLIF818000352026-06-09
00196449035243Anatomic Access LLIF818000002026-06-09
00196449035250Anatomic Access LLIF818000012026-06-09
00196449035267Anatomic Access LLIF818000022026-06-09
00196449035281Anatomic Access LLIF818000042026-06-09
00196449035298Anatomic Access LLIF818000052026-06-09
00196449035304Anatomic Access LLIF818000062026-06-09
00196449035311Anatomic Access LLIF818000072026-06-09
00196449035328Anatomic Access LLIF818000082026-06-09
00196449035335Anatomic Access LLIF818000092026-06-09
00196449035366Anatomic Access LLIF818000122026-06-09
00196449035380Anatomic Access LLIF818000142026-06-09
00196449035397Anatomic Access LLIF818000152026-06-09
00196449035441Anatomic Access LLIF818000202026-06-09
00196449035465Anatomic Access LLIF818000222026-06-09
00196449035472Anatomic Access LLIF818000232026-06-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00199150002139N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00199150002146N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754730N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00763000754747N/AMEDTRONIC SOFAMOR DANEK, INC.LXH2026-07-16
00822409082124N/AOrtho Development CorporationLXH2026-07-16
00822409082131N/AOrtho Development CorporationLXH2026-07-16
00822409082148N/AOrtho Development CorporationLXH2026-07-16
00822409082155N/AOrtho Development CorporationLXH2026-07-16
00822409082162N/AOrtho Development CorporationLXH2026-07-16
00822409082179N/AOrtho Development CorporationLXH2026-07-16
00822409082186N/AOrtho Development CorporationLXH2026-07-16
00822409082193N/AOrtho Development CorporationLXH2026-07-16
00822409082209N/AOrtho Development CorporationLXH2026-07-16
00822409082216N/AOrtho Development CorporationLXH2026-07-16
00822409082223N/AOrtho Development CorporationLXH2026-07-16
00822409082230N/AOrtho Development CorporationLXH2026-07-16
00822409082247N/AOrtho Development CorporationLXH2026-07-16
00822409082254N/AOrtho Development CorporationLXH2026-07-16
00822409082261N/AOrtho Development CorporationLXH2026-07-16
00822409082278N/AOrtho Development CorporationLXH2026-07-16
00822409082285N/AOrtho Development CorporationLXH2026-07-16
00822409082292N/AOrtho Development CorporationLXH2026-07-16
00822409082308N/AOrtho Development CorporationLXH2026-07-16
00822409082315N/AOrtho Development CorporationLXH2026-07-16
00822409082322N/AOrtho Development CorporationLXH2026-07-16
00822409082339N/AOrtho Development CorporationLXH2026-07-16
00822409082346N/AOrtho Development CorporationLXH2026-07-16
00840606188135Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188142Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16
00840606188159Ventana ASPINAL ELEMENTS, INC.LXH2026-07-16