FDA.reportPublic FDA data

-3mm Cutting Guide Depth Adaptor

Primary DI
05065012584356
Brand
-3mm Cutting Guide Depth Adaptor
Company
EVENTUM ORTHOPAEDICS LTD
Model
DA013
Device description
Allows for a 3mm adjustment resection of the patella
Published
2025-02-19
Public version status
New
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
05065012584356PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05065012584356050650125843565065012584356

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

Contacts#

Phone, Email table
PhoneEmail
+442045428754regulatory@eventumortho.com

Regulatory Flags#

DUNS number
226230358
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
05065012584257Reusable 5mm Pro ShimRS5002026-02-05
05065012584264Reusable 5mm 2.5 degree Pro shimRS50A2026-02-05
05065012584271Reusable 6mm Pro shimRS6002026-02-05
05065012584288Reusable 6mm 2.5 degree Pro shimRS60A2026-02-05
05065012584295Reusable 7mm Pro shimRS7002026-02-05
05065012584301Reusable 7mm 2.5 degree Pro shimRS70A2026-02-05
05065012584318Reusable 8mm Pro shimRS8002026-02-05
05065012584325Reusable 8mm 2.5 degree Pro shimRS80A2026-02-05
05065012584493Quadsense ProSE0022025-04-04
05065012584189Reusable 6mm shimRS0012025-02-19
05065012584196Reusable 7mm shimRS0022025-02-19
05065012584202Reusable 6mm 2.5 degree shimRS0032025-02-19
05065012584219Reusable 7mm 2.5 degree shimRS0042025-02-19
05065012584226Extraction ToolET0012025-02-19
05065012584332-1mm Cutting Guide Depth AdaptorDA0112025-02-19
05065012584349-2mm Cutting Guide Depth AdaptorDA0122025-02-19
05065012584363-4mm Cutting Guide Depth AdaptorDA0142025-02-19
05065012584387-6mm First Cut AdaptorGG0162025-02-19
05065012584394-7mm First Cut AdaptorGG0172025-02-19
05065012584455Cutting Guide Angle Adaptor LM 2.5 DegreeAA0152025-02-19

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