FDA.reportPublic FDA data

CREO

Primary DI
00193982572983
Brand
CREO
Company
GLOBUS MEDICAL, INC.
Model
6120.5086
Catalog number
6120.5086
Device description
Rigid Screwdriver Outer Sleeve, Threaded
Published
2026-06-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWPAPPLIANCE, FIXATION, SPINAL INTERLAMINAL
KWQAppliance, fixation, spinal intervertebral body
MNHOrthosis, spondylolisthesis spinal fixation
MNIOrthosis, spinal pedicle fixation
NKBThoracolumbosacral pedicle screw system
OSHPedicle screw spinal system, adolescent idiopathic scoliosis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
KWQAppliance, Fixation, Spinal Intervertebral BodyOrthopedic2
MNHOrthosis, Spondylolisthesis Spinal FixationOrthopedic2
MNIOrthosis, Spinal Pedicle FixationOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2
OSHPedicle Screw Spinal System, Adolescent Idiopathic ScoliosisOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K124058000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K124058000CREO STABILIZATION SYSTEMGlobus Medical, Inc.2013-05-13OSH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982572983PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982572983001939825729831939825729830193982572983

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
Length0

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
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
00193982587307CAPTIVATE3188.31173188.31172026-06-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWQ2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNI2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.OSH2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-28
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.MNH2026-06-28
00643169101296MSB VERTEX® Reconstruction SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-06-27
00810017913893Saber-C Body (PT), 14x17x6 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913909Saber-C Body (PT), 14x17x7 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913916Saber-C Body (PT), 14x17x8 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017913923Saber-C Body (PT), 14x17x9 6 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914357Saber-C Plate, 12x15x5 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914364Saber-C Plate, 12x15x6 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914371Saber-C Plate, 12x15x7 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914388Saber-C Plate, 12x15x8 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914395Saber-C Plate, 12x15x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914401Saber-C Plate, 12x15x10 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
00810017914630Saber-C Plate, 14x17x9 12 deg.ELEVATION SPINE, INC.KWQ2026-06-25
10889981441555VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441555VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441609VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441616VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441623VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationKWP2026-06-24
10889981441661VIRATASeaspine Orthopedics CorporationNKB2026-06-24
10889981005115NewportSeaspine Orthopedics CorporationMNH2015-09-24
10889981005115NewportSeaspine Orthopedics CorporationMNI2015-09-24