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Data / Medical devices / United States / Curiteva, Inc.

Curiteva, Inc.: FDA-registered device maker in Tanner, AL, United States, 13 510(k) clearances

Curiteva, Inc. is registered with the FDA (registration 3012131184) in Tanner, AL, United States. It lists 22 device types. The FDA files 13 510(k) clearances under its listings, the newest dated January 15, 2026. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this oneWatch Curiteva, Inc.
FDA registration number
3012131184
Address
25127 Will Mccomb DR, Tanner, AL, United States, 35671
Owner or operator
Curiteva, Inc. (10050404)
Roles
Contract manufacturer, Manufacturer
First device listed
November 13, 2015
Registered through
2026
Brand names listed
04-9011 Tapered Hex Screwdriver 2.5mm (Shaft 04-9013) (Handle 04-9040), 04-SB-3520 3.5x20mm, Bias Angle Smooth Shank Polyaxial Screw, 04-SB-3522 3.5x22mm, Bias Angle Smooth Shank Polyaxial Screw, 04-SB-3524 3.5x24mm, Bias Angle Smooth Shank Polyaxial Screw, 04-SB-3526 3.5x26mm, Bias Angle Smooth Shank Polyaxial Screw, 04-SB-3528 3.5x28mm, Bias Angle Smooth Shank Polyaxial Screw, 04-SB-3530 3.5x30mm, Bias Angle Smooth Shank Polyaxial Screw, 04-SB-3532 3.5x32mm, Bias Angle Smooth Shank Polyaxial Screw and more

Devices it lists

DeviceProduct codeClassRoleSource
Appliance, Fixation, Spinal InterlaminalKWP2Contract manufacturer, Manufactureraccessdata.fda.gov
Appliance, Fixation, Spinal Intervertebral BodyKWQ2Contract manufacturer, Manufactureraccessdata.fda.gov
BenderHXW1Contract manufactureraccessdata.fda.gov
ExtractorHWB1Contract manufactureraccessdata.fda.gov
Gauge, DepthHTJ1Contract manufactureraccessdata.fda.gov
Guide, Surgical, InstrumentFZX1Contract manufactureraccessdata.fda.gov
ImpactorHWA1Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, CervicalODP2Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, LumbarMAX2Contract manufacturer, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Bone Graft, ThoracicPHM2Contract manufacturer, Manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, CervicalOVE2Contract manufactureraccessdata.fda.gov
Intervertebral Fusion Device With Integrated Fixation, LumbarOVD2Contract manufacturer, Manufactureraccessdata.fda.gov
Orthopedic Manual Surgical InstrumentLXH1Contract manufactureraccessdata.fda.gov
Orthopedic Stereotaxic InstrumentOLO2Contract manufacturer, Manufactureraccessdata.fda.gov
Orthosis, Spine, Plate, Laminoplasty, MetalNQW2Manufactureraccessdata.fda.gov
Plate, Fixation, BoneHRS2Contract manufactureraccessdata.fda.gov
RetractorGAD1Contract manufactureraccessdata.fda.gov
Sacroiliac Joint FixationOUR2Manufactureraccessdata.fda.gov
Screw, Fixation, BoneHWC2Contract manufactureraccessdata.fda.gov
Spinal Vertebral Body Replacement Device - CervicalPLR2Contract manufactureraccessdata.fda.gov
Spinous Process PlatePEK2Contract manufactureraccessdata.fda.gov
Thoracolumbosacral Pedicle Screw SystemNKB2Contract manufacturer, Manufactureraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
January 15, 2026K254061Curiteva Porous PEEK Cervical Interbody Fusion SystemODPSubstantially EquivalentCuriteva, Inc.accessdata.fda.gov
June 18, 2025K250845Curiteva Porous PEEK Standalone ALIF SystemOVDSubstantially EquivalentCuriteva, Inc.accessdata.fda.gov
February 29, 2024K233360Curiteva Thoracolumbar Plate SystemKWQSubstantially EquivalentCuriteva, Inc.accessdata.fda.gov
January 18, 2024K233744Curiteva Porous PEEK Lumbar Interbody Fusion SystemMAXSubstantially EquivalentCuriteva, Inc.accessdata.fda.gov
June 28, 2023K231232Curiteva Laminoplasty SystemNQWSubstantially EquivalentCuriteva, Inc.accessdata.fda.gov
February 13, 2023K213030Curiteva Porous PEEK Cervical Interbody Fusion SystemODPSubstantially EquivalentCuriteva, Inc.accessdata.fda.gov
January 6, 2023K223200Curiteva Navigation SystemOLOSubstantially EquivalentCuriteva, Inc.accessdata.fda.gov
September 9, 2021K210402Curiteva Sacroiliac Joint Fusion SystemOURSubstantially EquivalentCuriteva, Inc.accessdata.fda.gov
August 28, 2019K191810Curiteva Pedicle Screw SystemNKBSubstantially EquivalentCuriteva, Inc.accessdata.fda.gov
December 20, 2018K181589Curiteva Lumbar Interbody Fusion SystemMAXSubstantially EquivalentCuriteva, LLCaccessdata.fda.gov
August 3, 2018K181549Curiteva Midline Anterior Cervical Plate System (or Curiteva Anterior Cervical Plate System)KWQSubstantially EquivalentCuriteva, LLCaccessdata.fda.gov
August 2, 2018K181562Curiteva Anterior Cervical Plate SystemKWQSubstantially EquivalentCuriteva, LLCaccessdata.fda.gov
July 9, 2018K181261Curiteva Cervical Interbody Fusion SystemODPSubstantially EquivalentCuriteva, LLCaccessdata.fda.gov

Compare with other makers

Updated January 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.