FDA.reportPublic FDA data

Prodigy Pedicle Screw System

Primary DI
B648C5044550DT0
Brand
Prodigy Pedicle Screw System
Company
CURITEVA, INC.
Model
C504-4550-DT
Device description
Dual Thread Extended Top Pedicle Screw, 4.5 x 50mm
Published
2023-12-29
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
B648C5044550DT0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Bone-screw internal spinal fixation system, non-sterileAn assembly of non-sterile implantable devices intended to provide immobilization and stabilization of spinal segments in the treatment of various spinal instabilities or deformities, also used as an adjunct to spinal fusion [e.g., for degenerative disc disease (DDD)]. Otherwise known as a pedicle screw instrumentation system, it typically consists of a combination of anchors (e.g., bolts, hooks, pedicle screws or other types), interconnection mechanisms (incorporating nuts, screws, sleeves, or bolts), longitudinal members (e.g., plates, rods, plate/rod combinations), and/or transverse connectors. Non-sterile disposable devices associated with implantation may be included.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length50Millimeter
Outer Diameter4.5Millimeter

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
B648C284302412121Inspire Lumbar Interbody Fusion SystemC284-302412-122026-07-06
B648C284302412141Inspire Lumbar Interbody Fusion SystemC284-302414-122026-07-06
B648C284302412161Inspire Lumbar Interbody Fusion SystemC284-302416-122026-07-06
B648C28430241861Inspire Lumbar Interbody Fusion SystemC284-302418-62026-07-06
B648C29515000Savant Lumbar Interbody Fusion SystemC295-15002026-07-06
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B678520297S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520298S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
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B678520300S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520301S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520302S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520303S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520304S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520305S0PressONNEXUS SPINE, L.L.C.NKB2026-07-10
B678520306S0PressON™NEXUS SPINE, L.L.C.NKB2026-07-10
B678520485S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520486S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520487S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520488S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520489S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520490S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520491S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520492S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520493S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520494S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520495S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
B678520496S0PressON Pedicle Screw SystemNEXUS SPINE, L.L.C.NKB2026-07-10
00643169465879MSB CD HORIZON Spinal SystemMEDTRONIC SOFAMOR DANEK, INC.NKB2026-06-28
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