FDA.reportPublic FDA data

CREO

Primary DI
00889095852318
Brand
CREO
Company
GLOBUS MEDICAL, INC.
Model
1192.1350
Device description
CREO Fenestrated 4.5 x 50mm Modular Screw
Published
2021-03-31
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
K182375000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182375000CREO® Stabilization System, Navigation Instruments, ExcelsiusGPS®Globus Medical, Inc.2019-04-08NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889095852318PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889095852318008890958523188890958523180889095852318

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
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
00889095401929ANTHEM2171.65192171.65192026-09-25
00889095402285ANTHEM2171.65552171.65552026-09-25
00889095402438ANTHEM2171.65702171.65702026-09-25
00889095402483ANTHEM2171.65752171.65752026-09-25
00889095402537ANTHEM2171.65802171.65802026-09-25
00889095411263ANTHEM7171.55097171.55092026-09-25
00889095411287ANTHEM7171.55117171.55112026-09-25
00889095411300ANTHEM7171.55137171.55132026-09-25
00889095411324ANTHEM7171.55157171.55152026-09-25
00889095611274ANTHEM2171.65852171.65852026-09-25
00193982003630N/A6190.00266190.00262026-08-14
00193982016340N/A6178.01676178.01672026-08-14
00193982096274ANTHEM2170.10362170.10362026-08-14
00193982096298ANTHEM2170.10382170.10382026-08-14
00193982096311ANTHEM2170.10402170.10402026-08-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00197157118280ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118297ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118303ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118310ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118327ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118334ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118341ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118358ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118365ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118372ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118389ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118396ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118402ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118419ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118426ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118433ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118440ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118457ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118464ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118471ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118488ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118495ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118501ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118518ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118525ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118532ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118549ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118556ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118563ZAVATION SCREWZavation LLCNKB2026-10-01
00197157118570ZAVATION SCREWZavation LLCNKB2026-10-01