FDA.reportPublic FDA data

Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®

Primary DI
B648C72430241081
Brand
Inspire®SA 3D Printed Trabecular PEEK™ with HAFUSE®
Company
CURITEVA, INC.
Model
C724-302410-8
Device description
30 (W) X 24 (D) X 10 (H) X 8° (A) STANDALONE ALIF ASSEMBLY, POROUS PEEK
Published
2026-01-08
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MAXIntervertebral Fusion Device With Bone Graft, Lumbar
OVDIntervertebral Fusion Device With Integrated Fixation, Lumbar
PHMIntervertebral Fusion Device With Bone Graft, Thoracic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MAXIntervertebral Fusion Device With Bone Graft, LumbarOrthopedic2
OVDIntervertebral Fusion Device With Integrated Fixation, LumbarOrthopedic2
PHMIntervertebral Fusion Device With Bone Graft, ThoracicOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250845000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250845000Curiteva Porous PEEK Standalone ALIF SystemCuriteva, Inc.2025-06-18OVD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B648C72430241081PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Polymeric spinal interbody fusion cageA device intended to be implanted into the space of an intervertebral disc that has been partially or totally removed during surgery in order to allow bone fusion between two contiguous vertebral bodies, typically in the treatment of degenerative disc disease (DDD). It is in the form of a hollow, porous, threaded and/or fenestrated cylindrical or geometrical device made of non-bioabsorbable synthetic polymer [e.g., polyetheretherketone (PEEK)] that provides mechanical stability and sufficient space for therapeutic spinal bone fusion to occur; bone graft is typically used to help with osseointegration. Fixation screws and devices associated with implantation may be included with the device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Angle8degree
Height10Millimeter
Length30Millimeter
Width24Millimeter

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
074575332
Device count
1
Lot or batch
true
Expiration date on label
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
04251631420200NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420217NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420224NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420231NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420248NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420255NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420262NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420279NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420286NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420293NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420309NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420316NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420323NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420330NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420347NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420354NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420361NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420378NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420385NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420392NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420408NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420415NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420422NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420439NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420446NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420453NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
04251631420460NGM WAVE PLIF CageNGMedical GmbHMAX2026-07-06
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