FDA.reportPublic FDA data

NAVIGATION INSTRUMENTS

Primary DI
00889095717259
Brand
NAVIGATION INSTRUMENTS
Company
GLOBUS MEDICAL, INC.
Model
6149.9125
Device description
Tap for 4.0mm Screw, CT, GI1
Published
2018-08-04
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

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
K180690000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K180690000Navigation InstrumentsGlobus Medical, Inc.2018-06-25OLO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889095717259PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095717259008890957172598890957172590889095717259

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter3.9Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1(610)930-1800info@globusmedical.com

Regulatory Flags#

DUNS number
139105691
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889095205831XEMPLIFI8103.0001S2015-10-10
00889095205848XEMPLIFI8103.0005S2015-10-10
00889095205855XEMPLIFI8103.0010S2015-10-10
00889095205862XEMPLIFI8103.0101S2015-10-10
00889095205879XEMPLIFI8103.0105S2015-10-10
00889095205886XEMPLIFI8103.0110S2015-10-10
00889095205893XEMPLIFI8103.0201S2015-10-10
00889095205909XEMPLIFI8103.0203S2015-10-10
00889095205916XEMPLIFI8103.0208S2015-10-10
00889095205923XEMPLIFI8103.0210S2015-10-10
00889095401820ANTHEM2171.65092171.65092026-09-25
00889095401844ANTHEM2171.65112171.65112026-09-25
00889095401868ANTHEM2171.65132171.65132026-09-25
00889095401882ANTHEM2171.65152171.65152026-09-25
00889095401905ANTHEM2171.65172171.65172026-09-25
00889095401929ANTHEM2171.65192171.65192026-09-25
00889095402285ANTHEM2171.65552171.65552026-09-25
00889095402438ANTHEM2171.65702171.65702026-09-25
00889095402483ANTHEM2171.65752171.65752026-09-25
00889095402537ANTHEM2171.65802171.65802026-09-25

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Primary DI, Brand, Company table
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00889024674790ROSA PIN STABILIZER 60MMOrthosoft IncOLO2025-12-12
00889024674776ROSA POLYAXIAL REFERENCE SIZE 3Orthosoft IncOLO2025-12-11
00889024674783ROSA POLYAXIAL REFERENCE SIZE 6Orthosoft IncOLO2025-12-11
00889024674806ROSA STABILIZER TISSUE DEFLECTOR 60MMOrthosoft IncOLO2025-12-11
00889024687455ROSA® KneeOrthosoft IncOLO2025-11-21
07613252286578FLUOROMAPStryker Leibinger GmbH & Co. KGOLO2025-01-28
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00887868558306ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575105ROSA® ShoulderOrthosoft IncOLO2024-03-06
00887868575112ROSA® ShoulderOrthosoft IncOLO2024-03-06