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

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
00889095258516CONCORD4129.2000S2015-11-07
00889095258523CONCORD4129.4000S2015-11-07
00889095343045CONCORD458.693S2015-12-09
00889095358230CONCORD4129.2020S2024-12-01
00889095358247CONCORD4129.4040S2024-12-01
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840019978507Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978514Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978521Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978538Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978545Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978552Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978569Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978576Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978583Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978590Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978606Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978613Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978620Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978637Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978644Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978651Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978668Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978675Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978682Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978699Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978705Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978712Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978729Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978736Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978743Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978750Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978767Reform TiPRECISION SPINE, INC.KWP2026-11-05
00840019978774Reform TiPRECISION SPINE, INC.KWP2026-11-05