OrthoGrid Hip Trauma

Primary DI
00860003424827
Brand
OrthoGrid Hip Trauma
Company
Orthogrid Systems, Inc.
Model
2010-915-502
Device description
OrthoGrid Trauma for non-invasive software system that provides image analysis tools for trauma procedures
Published
2021-08-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K192279000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192279000PhantomMSK TraumaOrthoGrid Systems, Inc.2019-12-07LLZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003424827PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003424827008600034248278600034248270860003424827

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.

Regulatory Flags#

DUNS number
079674160
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024707092OrthoGrid®20-8025-500-002026-07-15
00889024707443OrthoGrid®20-8025-110-002026-07-15
00889024707450OrthoGrid®20-8025-210-002026-07-15
00860003424841OrthoGrid Hip Trauma2010-915-5072025-06-24
00860003424858Orthogrid Calibration Array1020-915-1232025-06-24
00860003424865Orthogrid Calibration Array1020-915-1242025-06-24
00860003424834OrthoGrid Hip AI1015-915-5052022-05-19
00860003424803OrthoGrid Hip1015-915-5042021-03-05
00860003424810OrthoGrid Hip Preservation4015-915-5012021-03-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08437021722109ADAS 3DADAS3D MEDICAL S.L.LLZ2026-09-18
07350092810722Sectra Orthopedic PackageSectra ABLLZ2026-09-06
00754016387128ANDIImeka Solutions IncLLZ2026-05-14
00198953059173ViewPointGE Healthcare GmbHLLZ2026-02-27
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00817886020660JointsMEDSTRAT, INC.LLZ2025-08-09
00817886020653JointsMEDSTRAT, INC.LLZ2025-06-27
00860003424841OrthoGrid Hip TraumaOrthogrid Systems, Inc.LLZ2025-06-24
00817886020646JointsMEDSTRAT, INC.LLZ2025-04-30
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00350227000520EaglesoftPATTERSON TECHNOLOGY CENTERLLZ2023-10-25
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00817886020509JointsMEDSTRAT, INC.LLZ2023-04-03