FDA Registration
Active
🇺🇸 United States
CURITEVA, INC.
Reg #: 3012131184
·
FEI: 3012131184
·
Expires 2026
Products
20
Proprietary Names
67
Establishment Types
2
Classifications
20
Registration Details
- Registration Name
- CURITEVA, INC.
- Registration Number
- 3012131184
- FEI Number
- 3012131184
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 25127 WILL MCCOMB DR
- City
- Tanner
- State
- AL
- ZIP
- 35671
- Country
- US
Regulatory Submissions
- 510(k) Number
- K181261
Owner / Operator
- Firm Name
- Curiteva, Inc.
- Operator Number
- 10050404
- Address
- 25127 Will McComb Drive
- City
- Tanner
- State
- AL
- Postal Code
- 35671
- Country
- US
- Correspondent
- Scott L Steelman
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2024-03-28 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-12-26 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-12-18 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2023-09-12 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2018-12-12 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2017-12-18 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2017-12-18 |
| Bender | HXW | Class 1 | Orthopedic | No | 2025-07-01 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2018-12-26 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-12-03 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2019-12-03 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2022-04-19 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2025-08-11 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2021-09-10 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2023-09-12 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2025-07-01 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2018-12-12 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2025-01-06 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2025-07-01 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2015-11-13 |
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
Aptitude Midline Anterior Cervical Plate System
Savant Lumbar Interbody Fusion System
Inspire Porous PEEK Cervical Interbody Fusion System (Add'l Sizes & IFU)
200-2001. SET SCREW.
08-0116 Slimplicity Solo Plate 1-Level 16mm
FlareHawk
Inspire Porous PEEK Lumbar Interbody Fusion System
22-1001-25 RCS Buttress Plate 25mm
Tiger Headless Cannulated Screws
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Medical Device