FDA.reportPublic FDA data

QUARTEX

Primary DI
00193982320560
Brand
QUARTEX
Company
GLOBUS MEDICAL, INC.
Model
6149.8002
Device description
Connector Inserter, Pin
Published
2021-10-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
NKGPosterior cervical screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKGPosterior Cervical Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K211957000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K211957000QUARTEX Occipito-Cervico-Thoracic Spinal System, Globus Navigation InstrumentsGlobus Medical, Inc.2021-08-18NKG

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982320560PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982320560001939823205601939823205600193982320560

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
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
00193982572983CREO6120.50866120.50862026-06-10
00193982586393CAPTIVATE3188.25113188.25112026-06-10
00193982586416CAPTIVATE3188.25133188.25132026-06-10
00193982586430CAPTIVATE3188.25153188.25152026-06-10
00193982586454CAPTIVATE3188.25173188.25172026-06-10
00193982586478CAPTIVATE3188.25193188.25192026-06-10
00193982586690CAPTIVATE3188.26143188.26142026-06-10
00193982586706CAPTIVATE3188.26153188.26152026-06-10
00193982586713CAPTIVATE3188.26163188.26162026-06-10
00193982586720CAPTIVATE3188.26173188.26172026-06-10
00193982586737CAPTIVATE3188.26183188.26182026-06-10
00193982586744CAPTIVATE3188.26193188.26192026-06-10
00193982586973CAPTIVATE3188.30113188.30112026-06-10
00193982586997CAPTIVATE3188.30133188.30132026-06-10
00193982587017CAPTIVATE3188.30153188.30152026-06-10
00193982587031CAPTIVATE3188.30173188.30172026-06-10
00193982587055CAPTIVATE3188.30193188.30192026-06-10
00193982587277CAPTIVATE3188.31143188.31142026-06-10
00193982587284CAPTIVATE3188.31153188.31152026-06-10
00193982587291CAPTIVATE3188.31163188.31162026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00763000992316INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992323INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992330INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992347INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00763000992453INFINITY™ Occipitocervical Upper Thoracic SystemMEDTRONIC SOFAMOR DANEK, INC.NKG2026-07-24
00840606192057Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192064Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192071Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192088Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192095Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192101Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192118Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192125Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192132Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192149Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192156Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192163Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192170Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192187Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192194Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192200Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192217Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192224Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192231Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192248Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192255Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192262Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192279Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192286Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24
00840606192293Overwatch PCFSPINAL ELEMENTS, INC.NKG2026-07-24