FDA.reportPublic FDA data

QUARTEX

Primary DI
00193982316570
Brand
QUARTEX
Company
GLOBUS MEDICAL, INC.
Model
1149.8584
Device description
Closed CT 3.2-4.0 to Closed TL 5.5-6.35, Rod Adapter
Published
2021-10-09
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
00193982316570PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982316570001939823165701939823165700193982316570

GMDN Terms#

Term, Definition table
TermDefinition
Trans-facet-screw internal spinal fixation system, sterileA sterile device assembly that consists of rods, plates, and facet fixation screws where the screws are inserted bilaterally through and across the facet joint (spinal joint), i.e., trans-facet, at a single or multiple levels to stabilize and fuse vertebrae with compression in the treatment of various spinal conditions.

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
00849044040517N/A632.3002016-01-23
00193982662295ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00012026-03-30
00193982662301ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00022026-03-30
00193982662318ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00032026-03-30
00193982662325ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00502026-03-30
00193982662332ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00702026-03-30
00193982662349ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.00902026-03-30
00193982662356ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10502026-03-30
00193982662363ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10702026-03-30
00193982662370ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.10902026-03-30
00193982662387ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20502026-03-30
00193982662394ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20902026-03-30
00193982677411ORTHOPEDIC MANUAL SURGICAL INSTRUMENT6234.20702026-03-30
00193982622312EXCELSIUSGPS6252.00482026-03-24
00193982622329EXCELSIUSGPS6252.00492026-03-24
00889095366631EXCELSIUS GPS6143.27022019-07-31
00889095740912EXCELSIUS GPS6143.25422018-06-27
00889095782455CREO6200.10902019-07-31
00889095782462CREO6200.10952019-07-31
00889095782479CREO6200.14002019-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04052536162109neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162109neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162123neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162185neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162192neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536162208neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194285neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194285neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194292neon3Ulrich GmbH & Co. KGKWP2026-06-08
04052536194292neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194308neon3Ulrich GmbH & Co. KGNKG2026-06-08
04052536194308neon3Ulrich GmbH & Co. KGKWP2026-06-08
00197157082031ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082048ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082055ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082062ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082079ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082086ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082093ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082109ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082116ZAVATION SCREWZavation LLCKWP2026-06-05
00197157082123ZAVATION SCREWZavation LLCKWP2026-06-05
00840283403897VySpan™VY SPINE LLCKWP2026-06-05
00840283403897VySpan™VY SPINE LLCNKG2026-06-05
00840283403927VySpan™VY SPINE LLCKWP2026-06-05
00840283403927VySpan™VY SPINE LLCNKG2026-06-05