FDA.reportPublic FDA data

Reusable 6mm shim

Primary DI
05065012584189
Brand
Reusable 6mm shim
Company
EVENTUM ORTHOPAEDICS LTD
Model
RS001
Device description
6mm spacer for patella assessment.
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
05065012584189PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05065012584189050650125841895065012584189

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. This is a reusable device.

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
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
05065012584356-3mm Cutting Guide Depth AdaptorDA0132025-02-19
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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