FDA.reportPublic FDA data

Prodigy Pedicle Screw System

Primary DI
B648C5259000
Brand
Prodigy Pedicle Screw System
Company
CURITEVA, INC.
Model
C525-900
Device description
Offset MIS Pedicle Screw Sleeve, Right
Published
2024-01-05
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
B648C5259000PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implantation sleeve, reusableA hand-held tubular surgical device designed to be used during an orthopaedic implantation procedure to hold/grip an implant (e.g., an orthopaedic bone screw), facilitate the acceptance of an orthopaedic instrument (e.g., a screwdriver or a smaller diameter sleeve) through it, stabilize an instrument/implant coupling, and/or protect the surgeon's gloved hand or patient tissue. It is not primarily intended to place, angle, and guide a rotating surgical drill. It is typically made of high-grade stainless steel and/or synthetic materials and is available in various sizes and lengths. This is a reusable device.

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
00197157075835ZAVATION DRIVERZavation LLCNKB2026-05-27
00197157075842ZAVATION K-WIREZavation LLCNKB2026-05-27
06009699901715Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
06009699901722Titamed Spinal SystemTITAMED (PTY) LTDNKB2026-05-27
00810088650970Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651052Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651144Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651151Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651168Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651175Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651182Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
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00810088651380Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651397Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
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00810088651595Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651601Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651618Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651625Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651632Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651809Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651816Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651823Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651830Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651847Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088651854Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652035Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12
00810088652042Goblin Pedicle Screw SystemMEDYNUS, INC.NKB2022-04-12