FDA.reportPublic FDA data

NavitrackER

Primary DI
00889024304222
Brand
NavitrackER
Company
Orthosoft Inc
Model
20-8000-000-07
Catalog number
20-8000-000-07
Published
2016-09-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
HAWNeurological Stereotaxic Instrument
OLOOrthopedic Stereotaxic Instrument

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HAWNeurological Stereotaxic InstrumentNeurology2
OLOOrthopedic Stereotaxic InstrumentNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030827000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030827000NAVITRACK SYSTEM: TOTAL HIP REPLACEMENT CT-FREE CUP, MODEL 900.204Orthosoft, Inc.2003-05-23HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024304222PrimaryGS10
00889024466333Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024304222008890243042228890243042220889024304222
00889024466333008890244663338890244663330889024466333

GMDN Terms#

Term, Definition table
TermDefinition
Imaging lesion localization marker, external, single-useA device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1(800)-348-2759zimmer.consumerrelations@zimmer.com

Regulatory Flags#

DUNS number
205670032
Device count
6
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00887868558467iASSIST® Knee System302.4021302.40212022-09-21
00887868558474iASSIST® Knee System20-8011-900-1320-8011-900-132022-09-21
00889024211605NA302.4002302.40022016-09-14
00889024211636iASSIST302.4001302.40012016-09-14
00889024305083Sesamoid20-8000-070-3520-8000-070-352016-09-12
00889024305090Sesamoid20-8000-070-3620-8000-070-362016-09-12
00889024305106Sesamoid20-8000-070-3720-8000-070-372016-09-12
00889024305113Sesamoid20-8000-070-3820-8000-070-382016-09-12
00889024305120Sesamoid20-8000-070-3920-8000-070-392016-09-12
00889024305205Sesamoid20-8000-070-6420-8000-070-642016-09-12
00889024478954Sesamoid Plasty V2 Stand20-8000-070-8020-8000-070-802016-12-21
00889024478961Camera Kit20-8000-070-9920-8000-070-992016-12-21
00889024478978Sesamoid Plasty V2 Computer Kit20-8000-070-7720-8000-070-772016-12-21
00889024485518AC power cord North America20-8000-070-7120-8000-070-712016-12-21
00889024488502Sesamoid Plasty V2 HDMI Cable 30'20-8000-071-242017-04-10
00889024492752NA20-8000-070-212017-09-12
00889024492769NA20-8000-070-462017-09-12
00889024511026ROSA® Recon Platform20-8020-100-0120-8020-100-012019-03-06
00889024511170ROSA® Recon20-8020-110-0120-8020-110-012019-03-06
00889024511323ROSA® KNEE OPTICAL UNIT20-8020-120-0120-8020-120-012019-03-06

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