CURITEVA, INC.

FDA Device Registration & Listing · Tanner, AL, US · Registration 3012131184

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3012131184
FEI Number
3012131184
Entity Name
CURITEVA, INC.
City/State/Country
Tanner, AL, US
Establishment Address
25127 WILL MCCOMB DR, Tanner, AL 35671, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Curiteva, Inc. (Owner Number: 10050404)
Owner / Operator Contact Address
25127 Will McComb Drive, Tanner, AL 35671, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Sage Cervical Interbody Fusion System Curiteva Navigation System Tiger Cannulated Screw System 29-MP-5055 Reli™ SP Plus 55mm Male Plate 29-0128 28mm Trial 29-MP-5028 Reli™ SP Plus 28mm Male Plate 29-FP-5045 Reli™ SP Plus 45mm Female Plate 29-FP-5028 Reli™ SP Plus 28mm Female Plate 29-0155 55mm Trial 29-0145 45mm Trial 29-0135 35mm Trial 29-FP-5055 Reli™ SP Plus 55mm Female Plate 29-MP-5035 Reli™ SP Plus 35mm Male Plate 29-MP-5045 Reli™ SP Plus 45mm Male Plate 29-FP-5035 Reli™ SP Plus 35mm Female Plate Remi Robotic Navigation System 10-IB30-11 VS ALIF Cage Plate Install Block 30 x 11 10-IB30-19 VS ALIF Cage Plate Install Block 30 x 19 10-IB30-17 VS ALIF Cage Plate Install Block 30 x 17 10-1008-2 ALIF Cage Plate Universal Awl (10-1018 Handle) 10-IB30-15 VS ALIF Cage Plate Install Block 30 x 15 10-IB30-13 VS ALIF Cage Plate Install Block 30 x 13 Aptitude Anterior Cervical Plate System Prodigy Pedicle Screw System FlareHawk11/TiHawk11 ACP122 Anterior Cervical Plate 1-Level 22mm ACP120 Anterior Cervical Plate 1-Level 20mm ACP124 Anterior Cervical Plate 1-Level 24mm Inspire Porous PEEK Cervical Interbody Fusion System Acumen Thoracolumbar Plate System Inspire Porous PEEK Standalone ALIF System 04-SB-4036 4x36mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4030 4x30mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3522 3.5x22mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3534 3.5x34mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3526 3.5x26mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4020 4x20mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3536 3.5x36mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4024 4x24mm, Bias Angle Smooth Shank Polyaxial Screw 04-9011 Tapered Hex Screwdriver 2.5mm (Shaft 04-9013) (Handle 04-9040) 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 04-SB-4038 4x38mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3520 3.5x20mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3540 3.5x40mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4032 4x32mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4034 4x34mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4022 4x22mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4028 4x28mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3524 3.5x24mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4026 4x26mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-3538 3.5x38mm, Bias Angle Smooth Shank Polyaxial Screw 04-SB-4040 4x40mm, Bias Angle Smooth Shank Polyaxial Screw SI-LUTION Sacroiliac Joint Fusion System Zavation Cervical Plate System 30-0122 1-Level Cervical Plate 22 Process Laminoplasty System FlareHawk Interbody Fusion System FlareHawk Interbody Fusion System Aptitude Midline Anterior Cervical Plate System Tiger Cannulated Screw System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2024-03-28
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2018-12-26
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2017-12-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-09-12
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2018-12-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-09-14
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2017-12-18
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2017-12-18
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-06-23
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2017-12-18
HXW Bender Orthopedic Class 1 888.4540 2025-07-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-12-26
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-12-03
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-12-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2022-04-19
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2020-03-19
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-05-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-12-18
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2023-03-21
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-03-01
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-08-11
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-08-11
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-08-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2017-12-18
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2021-09-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2017-12-18
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2023-09-12
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-29
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2021-01-29
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2018-12-26
HWB Extractor Orthopedic Class 1 888.4540 2025-07-01
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2018-12-12
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2022-09-14
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2018-12-12
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2025-01-06
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2020-03-19
HWA Impactor Orthopedic Class 1 888.4540 2025-07-01

Official Correspondent

Scott Steelman

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Curiteva, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K142269 Reliance Medical Systems, LLC Reliance Cervical IBF System 2015-06-09
K122085 Omni Surgical, LP Dba Spine360 STINGRAY CERVICAL CAGE 2012-10-17
K120275 Synthes (Usa), LLC SYNTHES ACIS/VERTEBRAL SPACER CR 2012-05-25
K062348 Medtronic Neurosurgery TIMESH SELF DRILLING SCREW 2006-09-08
K063244 Arc Surgical, LLC ARC SURGICAL BONE REDUCTION SCREW 2006-12-27

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0014-2014 Synthes USA HQ, Inc. 2
Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle.
Z-0026-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.2MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0026-2016 Ortho Solutions Inc 330 Franklin Tnpk 2
Ortho OS Solutions UltOS 3.5mm locking screw 12mm to 50mm Ortho Solutions LTD, Unit 5 West Station Business Park, Spital Road, Maldon, Essex CM96FF Rx Only a) Sterile b) Non-Sterile Orthopaedic Bone Screw
Z-0027-2013 Orthohelix Surgical Designs Inc 2
OrthoHelix Part #HCS-056-32 3.8MM Cannulated Hex Driver NON STERILE MAT: 465 SS The drivers are used to drive screws in the Mini MaxTorque Screw System, which is intended to be used to stabilize and aid in the fusion of fractures and osteotomies involving small bones of the hand, wrist, afoot, and ankle.
Z-0043-2018 MicroPort Orthopedics Inc. 2
MicroPort Orthopedics SCHANZ SCREW SELF DRILL, SIZE 4mm, REF 20070057, STERILE R Product Usage: MPO Total Hip Systems are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions: 1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia; 2. inflammatory degenerative joint disease such as rheumatoid arthritis; 3. correction of functional deformity; and, 4. revision procedures where other treatments or devices have failed

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012131184. Last updated year: 2026. Please use registration number 3012131184 when referencing this establishment in official correspondence.
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