FDA.reportPublic FDA data

OrthoGrid Hip

Primary DI
00860003424803
Brand
OrthoGrid Hip
Company
Orthogrid Systems, Inc.
Model
1015-915-504
Device description
OrthoGrid Hip 3.0 for non-invasive software system that provides image analysis tools for Total Hip Replacement
Published
2021-03-05
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
LLZSystem, Image Processing, Radiological

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LLZSystem, Image Processing, RadiologicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210136000PhantomMSK HipOrthoGrid Systems, Inc.2021-02-18LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003424803PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003424803008600034248038600034248030860003424803

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fluoroscopic grid softwareA software program intended for use during an orthopaedic surgical procedure to enhance fluoroscopic images with a visual tool in the form of an overlaid grid, whereby the grid is intended to highlight fluoroscopic distortion and e.g., assist placement of an implant.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
079674160
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003424841OrthoGrid Hip Trauma 2010-915-5072025-06-24
00860003424858Orthogrid Calibration Array 1020-915-1232025-06-24
00860003424865Orthogrid Calibration Array 1020-915-1242025-06-24
00860003424834OrthoGrid Hip AI1015-915-5052022-05-19
00860003424827OrthoGrid Hip Trauma 2010-915-5022021-08-27
00860003424810OrthoGrid Hip Preservation 4015-915-5012021-03-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08033837938835no brandCEFLA SOCIETA' COOPERATIVALLZ2026-05-11
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G725QFR310QFRQFR Solutions B.V.LLZ2026-05-11
08800130800080Laon OrthoLaon Medi Inc.LLZ2026-05-07
G713ELU0010ElucisRealize Medical Inc.LLZ2026-05-07
08437021468045QP-Brain®QUIBIM SOCIEDAD LIMITADA.LLZ2026-05-06
08437023642016NemoCastSOFTWARE NEMOTEC SLLLZ2026-04-23
08437023642023NemoFABSOFTWARE NEMOTEC SLLLZ2026-04-23
M722C26103V260970ClearRead CT ServerRiverain Technologies, Inc.LLZ2026-04-20
M722CC26103V260970ClearRead CT ConsoleRiverain Technologies, Inc.LLZ2026-04-20
EOLENEUROINSIGHTV1P00Neuro InsightOlea Medical USALLZ2026-04-13
EOLENEUROVASIV1P00Neurovascular InsightOlea Medical USALLZ2026-04-13
08056304455864Caas QardiaPie Medical Imaging B.V.LLZ2026-04-03
08800290066784EVO Q10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340506147EVO QH10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800340509988EVO XQ10 Diagnostic Ultrasound SystemSAMSUNG MEDISON CO., LTD.LLZ2026-04-03
08800066200619JLK-AILINKJLK, Inc.LLZ2026-03-25