FDA.reportPublic FDA data

Prodigy Pedicle Screw System

Primary DI
B648C504R55CCPB0
Brand
Prodigy Pedicle Screw System
Company
CURITEVA, INC.
Model
C504-R55CC-PB
Device description
5.5 x 500mm PRE-BENT ROD, COBALT CHROME
Published
2025-08-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Contact Domains#

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
K191810000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K191810000Curiteva Pedicle Screw SystemCuriteva, Inc.2019-08-28NKB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B648C504R55CCPB0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system sterilization container/implant setA collection of non-sterile, implantable components of a bone-screw internal spinal fixation system (e.g., rods, screws, connectors, hooks) supplied within a reusable sterilization container (i.e., all under the same product code) to be sterilized before they are implanted as part of an internal spinal fixation procedure. The set provides the surgeon with a selection of implants (e.g., different sizes) during surgery, whereby unused implants maybe resterilised for subsequent implantation in another patient. This is a reusable device which includes single-use implants.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length500Millimeter
Outer Diameter5.5Millimeter

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Contacts#

Phone, Email table
PhoneEmail
+1 (877) 928-7483support@curiteva.com

Regulatory Flags#

DUNS number
074575332
Device count
1
Lot or batch
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B648C4452100Savant Lumbar Interbody Fusion SystemC445-2102024-01-04
B648C4452200Savant Lumbar Interbody Fusion SystemC445-2202024-01-04
B648C2853000Inspire Lumbar Interbody Fusion SystemC285-3002026-01-09
B648C3051500Savant Lumbar Interbody Fusion SystemC305-1502026-01-09
B648C505420450Prodigy Pedicle Screw SystemC505-420-452026-01-09
B648C505420550Prodigy Pedicle Screw SystemC505-420-552026-01-09
B648C505420650Prodigy Pedicle Screw SystemC505-420-652026-01-09
B648C6151252750SI-LUTION Sacroiliac Joint Fusion SystemC615-125-2752026-01-09
B648C615125275E0SI-LUTION Sacroiliac Joint Fusion SystemC615-125-275E2026-01-09
B648C6151253000SI-LUTION Sacroiliac Joint Fusion SystemC615-125-3002026-01-09
B648C615125300E0SI-LUTION Sacroiliac Joint Fusion SystemC615-125-300E2026-01-09
B648C6151253250SI-LUTION Sacroiliac Joint Fusion SystemC615-125-3252026-01-09
B648C615125325E0SI-LUTION Sacroiliac Joint Fusion SystemC615-125-325E2026-01-09
B648C72540281420T0Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®C725-402814-20T2026-01-09
B648C11551560Acumen Thoracolumbar Plate SystemC1155-1562026-01-08
B648C25213000Prodigy Pedicle Screw SystemC525-13002026-01-08
B648C2851000Inspire Lumbar Interbody Fusion SystemC285-1002026-01-08
B648C2852000Inspire Lumbar Interbody Fusion SystemC285-2002026-01-08
B648C2951200090Savant Lumbar Interbody Fusion SystemC295-1200-092026-01-08
B648C2951200100Savant Lumbar Interbody Fusion SystemC295-1200-102026-01-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03700780634583Erisma®-LPCLARIANCENKB2026-05-28
04052536085491neon3Ulrich GmbH & Co. KGKWP2026-05-28
06009699900008Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900503Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900817Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900831Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900848Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900855Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900862Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900879Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900886Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900893Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900909Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900916Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900923Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900930Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900947Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900954Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900961Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900978Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900985Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699900992Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901005Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901012Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901029Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901036Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901043Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901050Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901067Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28
06009699901074Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-28