FDA.reportPublic FDA data

E-GPS Navigated Instrument System

Primary DI
00840019970747
Brand
E-GPS Navigated Instrument System
Company
PRECISION SPINE, INC.
Model
75-RT-1750
Catalog number
75-RT-1750
Device description
Locking MIS Driver, Reform Ti, Cannulated
Published
2024-01-04
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
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K220862000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K220862000E-GPS Navigated InstrumentsPrecision Spine, Inc.2022-07-14OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840019970747PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840019970747008400199707478400199707470840019970747

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic surgical procedure kit, non-medicated, reusableA collection of various orthopaedic surgical instruments, dressings and the necessary materials intended to be used to perform an orthopaedic surgical procedure, however the kit is not dedicated to orthopaedic implantation. It does not contain pharmaceuticals. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
079398589
Device count
1
DM exempt
true
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815362021446Slimplicity Anterior Cervical Plate System08-902008-90202019-04-01
00815362021453Slimplicity Anterior Cervical Plate System08-902108-90212019-04-01
00815362021460Slimplicity Anterior Cervical Plate System08-902408-90242019-04-01
00815362021477Slimplicity Anterior Cervical Plate System08-902508-90252019-04-01
00815362021484Slimplicity Anterior Cervical Plate System08-902608-90262019-04-01
00815362021729Slimplicity Anterior Cervical Plate System50-001850-00182019-04-01
00815362021088Slimplicity Anterior Cervical Plate System08-011208-01122019-03-29
00815362021118Slimplicity Anterior Cervical Plate System08-011808-01182019-03-29
00815362021125Slimplicity Anterior Cervical Plate System08-012008-01202019-03-29
00815362021132Slimplicity Anterior Cervical Plate System08-012208-01222019-03-29
00815362021149Slimplicity Anterior Cervical Plate System08-012408-01242019-03-29
00815362021156Slimplicity Anterior Cervical Plate System08-012608-01262019-03-29
00815362021163Slimplicity Anterior Cervical Plate System08-012808-01282019-03-29
00815362021170Slimplicity Anterior Cervical Plate System08-022608-02262019-03-29
00815362021187Slimplicity Anterior Cervical Plate System08-022808-02282019-03-29
00815362021194Slimplicity Anterior Cervical Plate System08-023008-02302019-03-29
00815362021200Slimplicity Anterior Cervical Plate System08-023208-02322019-03-29
00815362021217Slimplicity Anterior Cervical Plate System08-023408-02342019-03-29
00815362021224Slimplicity Anterior Cervical Plate System08-023608-02362019-03-29
00815362021231Slimplicity Anterior Cervical Plate System08-023808-02382019-03-29

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345700551NextAR TSA PlatformMedacta International SAOLO2026-07-10
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10705034647364CROSSNAV CONDUITMedos International SàrlOLO2026-07-09
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