FDA.reportPublic FDA data

Savant Lumbar Interbody Fusion System

Primary DI
B648C4451100
Brand
Savant Lumbar Interbody Fusion System
Company
CURITEVA, INC.
Model
C445-110
Device description
8mm Angled Right Rasp, Bayoneted
Published
2024-01-04
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
MAXIntervertebral Fusion Device With Bone Graft, Lumbar

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K181589000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K181589000Curiteva Lumbar Interbody Fusion SystemCuriteva, LLC2018-12-20MAX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B648C4451100PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation plate file/raspA hand-held manual instrument designed to blunt and smooth the sharp edges of an orthopaedic fixation plate that has been cut by the surgeon during orthopaedic surgery. It is made of metal materials and is in the form of a rod with an abrasive working end, typically coated with diamond particles. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length8Millimeter

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

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