FDA.reportPublic FDA data

Panel PC

Primary DI
05065012584516
Brand
Panel PC
Company
EVENTUM ORTHOPAEDICS LTD
Model
PC001
Device description
Medical computer loaded with Quadsense software.
Published
2025-01-22
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
ONNIntraoperative Orthopedic Joint Assessment Aid

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ONNIntraoperative Orthopedic Joint Assessment AidNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K241298000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K241298000QUADSENSEEventum Orthopaedics, Ltd.2024-10-04ONN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05065012584516PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05065012584516050650125845165065012584516

GMDN Terms#

Term, Definition table
TermDefinition
Arthroplasty force sensor display unitAn electrically-powered electronic device designed to wirelessly connect to an arthroplasty force sensor to display sensor readings in a graphical representation to facilitate assessment of bone resection lines and/or size or positioning of prosthesis components to be implanted. It consists of a computing device with installed dedicated application software, which may have a dedicated receiver.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity20 Percent (%) Relative Humidity80 Percent (%) Relative Humidity
Storage Environment Temperature10 Degrees Celsius35 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
226230358
Device count
1
Serial number
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00810832032328LanternOrthalign, Inc.ONN2025-12-29
00810832032489LanternOrthalign, Inc.ONN2025-12-12
00810832032243LanternOrthalign, Inc.ONN2025-11-19
00810832031994LanternOrthalign, Inc.ONN2025-09-12
00810832032311LanternOrthalign, Inc.ONN2025-05-06
00810832032335LanternOrthalign, Inc.ONN2025-05-06
00810832032229Lantern Orthalign, Inc.ONN2025-04-24
05065012584493Quadsense ProEVENTUM ORTHOPAEDICS LTDONN2025-04-04
05065012584158QuadsenseEVENTUM ORTHOPAEDICS LTDONN2025-01-22
05065012584233Dongle AssemblyEVENTUM ORTHOPAEDICS LTDONN2025-01-22
05065012584523TrollyEVENTUM ORTHOPAEDICS LTDONN2025-01-22
00810832031895Lantern Orthalign, Inc.ONN2024-12-13
00810832031901LanternOrthalign, Inc.ONN2024-12-13
00810832031918LanternOrthalign, Inc.ONN2024-12-13
00810832031925LanternOrthalign, Inc.ONN2024-12-13
00810832031932LanternOrthalign, Inc.ONN2024-12-13
00810832032014LanternOrthalign, Inc.ONN2024-12-13
00810832032021Lantern Orthalign, Inc.ONN2024-12-13
00810832032038Lantern Orthalign, Inc.ONN2024-12-13
00810832032045LanternOrthalign, Inc.ONN2024-12-13
00810832032069LanternOrthalign, Inc.ONN2024-12-13
00810832032076Lantern Orthalign, Inc.ONN2024-12-13
00810832032106Lantern Orthalign, Inc.ONN2024-12-13
00810832032120LanternOrthalign, Inc.ONN2024-12-13
00810832032137LanternOrthalign, Inc.ONN2024-12-13
00810832032144Lantern Surgical AssistantOrthalign, Inc.ONN2024-12-13
00810832032151LanternOrthalign, Inc.ONN2024-12-13
00810832032168LanternOrthalign, Inc.ONN2024-12-13
00810832032199LanternOrthalign, Inc.ONN2024-12-13
07613327581843VERASENSE Software ApplicationORTHOSENSOR INCONN2022-08-24