FDA.reportPublic FDA data

VYRSA General Instrument

Primary DI
G418VYFI1191030
Brand
VYRSA General Instrument
Company
Vyrsa Technologies
Model
VYFI-119-103
Device description
Tertiary Dilator
Published
2024-01-27
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
G418VYFI1191030PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic prosthesis implantation positioning instrument, reusableA hand-held surgical instrument intended to be used during implantation of an orthopaedic prosthesis, either manually or as a computer-assisted surgery (CAS) device, to aid in the navigation/placement of the prosthesis or other instruments [e.g., drill sleeves and guide wires (Kirschner wires), patella saw guide]. It may be used for the following applications: 1) to hold/align/fix/guide other instruments, prostheses, or prosthesis components; 2) to provide relative position landmarks; 3) to ascertain correct spatial orientation or limb alignment; and/or 4) as an interface (non-adaptive) between prosthesis components. This is a reusable device intended to be sterilized prior to use.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
083331321
Device count
1
Premarket exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
G418VY1000501800VYRSA General Instrument VY-100-05-01802024-01-27
G418VY1050010VYRSA General Instrument VY-105-0012024-01-27
G418VYPR1030020VYRSA ProVYPR-103-0022024-01-27
G418VYPR1030080VYRSA ProVYPR-103-0082024-01-27
G418VYPR1030090VYRSA ProVYPR-103-0092024-01-27
G418VYPR1310010VYRSA General Instrument VYPR-131-0012024-01-27
G418VYV11031210VYRSA V1VYV1-103-1212024-01-27
G418VYV1103121040VYRSA V1VYV1-103-121-042024-01-27
G418VYV11033210VYRSA V1VYV1-103-3212024-01-27
G418VYV1232608090VYRSA V1VYV1-2326-08092024-01-27
G418VYV1232608110VYRSA V1VYV1-2326-08112024-01-27
G418VYV1232608130VYRSA V1VYV1-2326-08132024-01-27
G418VY100330VYRSA General Instrument VY-100-332024-01-27
G418VY100340VYRSA General Instrument VY-100-342024-01-27
G418VY1010010VYRSA General Instrument VY-101-0012024-01-27
G418VY1040980VYRSA General Instrument VY-104-0982024-01-27
G418VY5000010VYRSA General InstrumentVY-500-0012024-01-27
G418VYFI070300VYRSA FixVYFI-07-0302024-01-27
G418VYFI070350VYRSA FixVYFI-07-0352024-01-27
G418VYFI070400VYRSA FixVYFI-07-0402024-01-27

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Primary DI, Brand, Company table
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00842078123584KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078124178Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
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00842078124215Lapidus Joint PrepEXTREMITY MEDICAL, LLCLXH2026-10-29
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00842078129616KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129623KinematX TotalEXTREMITY MEDICAL, LLCLXH2026-10-29
00842078129753IO FreedomEXTREMITY MEDICAL, LLCLXH2026-10-29
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