FDA.reportPublic FDA data

CREO

Primary DI
00193982069247
Brand
CREO
Company
GLOBUS MEDICAL, INC.
Model
7218.8910
Device description
CREO Preferred Angle Screw, 9.5x100mm, Cannulated, CoCr Head, Ti Shank
Published
2020-01-01
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
NKBThoracolumbosacral pedicle screw system

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWPAppliance, Fixation, Spinal InterlaminalOrthopedic2
NKBThoracolumbosacral Pedicle Screw SystemOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K191835000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191835000CREO Stabilization System, Navigation Instruments, ExcelsiusGPS InstrumentsGlobus Medical, Inc.2019-08-06NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00193982069247PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00193982069247001939820692471939820692470193982069247

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.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Outer Diameter9.5Millimeter

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
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.KWP2026-07-30
00763000887216MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-07-30
00840493425382RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425399RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425405RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425412RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425429RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425436RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425443RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425450RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425467RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425474RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425481RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425498RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425504RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425511RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425528RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425535RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840493425542RIVA Pedicle Screw SystemXENIX MEDICAL LLCNKB2026-07-28
00840606189927OMEGA XPSPINAL ELEMENTS, INC.KWP2026-07-28
00841732168527TAURUS Pedicle Screw SystemCTL Medical CorporationNKB2026-07-28
00841732168527TAURUS Pedicle Screw SystemCTL Medical CorporationKWP2026-07-28
07290117353738CarboClear Hybrid Pedicle Screw SystemCARBOFIX ORTHOPEDICS LTDNKB2026-07-27
00841732169272PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169289PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169296PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169302PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
00841732169319PICASSO MIS Spinal SystemCTL Medical CorporationNKB2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCKWP2026-07-24
10888857598164Xia® 3 System - Serrato®VB Spine LLCNKB2026-07-24