FDA.reportPublic FDA data

NAVITRACK

Primary DI
00889024489158
Brand
NAVITRACK
Company
Orthosoft Inc
Model
20-8000-020-22
Catalog number
20-8000-020-22
Published
2017-05-05
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
K032917000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K032917000NAVITRACK SYSTEM - TOTAL HIP REPLACEMENT CT-FREEOrthosoft, Inc.2003-10-21HAW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024489158PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024489158008890244891588890244891580889024489158

GMDN Terms#

Term, Definition table
TermDefinition
Surgical screwdriver, reusableA non-powered tool intended to fit into a screw head (e.g., slotted, cross/hex head) for the application of rotation to introduce/remove a screw (e.g., craniofacial bone screw, dental screw) into/from a patient in association with a surgical procedure [e.g., orthopaedic, dental, computer assisted surgery (CAS), image registration]. It may also be used to connect/disconnect a device to/from another device attached to a patient (e.g., implant component, fiducial marker). The proximal end of the device may have a handle for manual use or a profiled tang that fits into an independent chuck or power driver; it is typically made of metallic and/or polymer materials. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

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

Regulatory Flags#

DUNS number
205670032
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024673403NavitrackER®20-8087-000-0020-8087-000-002026-06-26
00889024707047Signature ONE Software Package302.4018302.40182026-07-10
00889024699762ROSA® Shoulder20-8087-142-0020-8087-142-002026-06-26
00889024699779ROSA® Shoulder20-8087-141-0020-8087-141-002026-06-26
00889024699786ROSA® Shoulder20-8087-150-0120-8087-150-012026-06-26
00889024699793ROSA® Shoulder20-8087-151-0020-8087-151-002026-06-26
00889024699809ROSA® Shoulder20-8087-150-0220-8087-150-022026-06-26
00889024699816ROSA® Shoulder20-8087-150-0320-8087-150-032026-06-26
00889024699823ROSA® Shoulder20-8087-140-0020-8087-140-002026-06-26
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810055525256Onyx 7.5mm Navigated Cannulated TapSi-Bone Inc.OLO2026-09-30
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00810055525270Onyx 5.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525287Onyx 6.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525294Onyx 7.5 mm Navigated Awl Tip TapSi-Bone Inc.OLO2026-09-30
00810055525720Onyx Navigated Locking DriverSi-Bone Inc.OLO2026-09-30
00810055525966Onyx Navigated Locking Driver, CannulatedSi-Bone Inc.OLO2026-09-30
00810055526284Onyx iGPS Awl Tip Tap 4.5mmSi-Bone Inc.OLO2026-09-30
00810055526291Onyx iGPS Awl Tip Tap 5.5mmSi-Bone Inc.OLO2026-09-30
00810055526307Onyx iGPS Awl Tip Tap 6.5mmSi-Bone Inc.OLO2026-09-30
00810055526314Onyx iGPS Awl Tip Tap 7.5mmSi-Bone Inc.OLO2026-09-30
00810055526321Onyx iGPS DriverSi-Bone Inc.OLO2026-09-30
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