FDA Registration
Active
🇺🇸 United States
CAPTIVA SPINE, Inc.
Reg #: 3006082533
·
FEI: 3006082533
·
Expires 2026
Products
17
Proprietary Names
22
Establishment Types
3
Classifications
17
Registration Details
- Registration Name
- CAPTIVA SPINE, Inc.
- Registration Number
- 3006082533
- FEI Number
- 3006082533
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 967 N HIGHWAY A1A ALT STE 1
- City
- Jupiter
- State
- FL
- ZIP
- 33477
- Country
- US
Regulatory Submissions
- 510(k) Number
- K193270
Owner / Operator
- Firm Name
- CAPTIVA SPINE
- Operator Number
- 9096708
- Address
- 967 Alternate A1A, SUITE 1
- City
- Jupiter
- State
- FL
- Postal Code
- 33477
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-07-25 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2020-03-02 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2009-12-08 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-08-19 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-08-19 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2015-10-19 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2009-12-08 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2021-08-16 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2012-12-13 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2019-07-25 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2019-07-25 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2019-05-20 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2009-12-08 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2024-02-28 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2009-12-08 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2009-12-08 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2009-12-08 |
Proprietary Names
Transfasten
CapLOX II_TowerLOX_4.5mm Screw
TowerLOX Pedicle Screw, Threshold Pedicular Fixation, CapLOX II Pedicle Screw, SmartLOX, PivoTec, FuseLox Cervical
TowerLOX Pedicle Screw System, Threshold Pedicular Fixation System, CapLOX II Pedicle Screw System
SmartLOX Cervical Plate System
TowerLOX MIS Ext Pedicle Screw System
TowerLOX Pedicle Screw, Threshold Pedicular Fixation, CapLOX II Pedicle Screw, SmartLOX, PivoTec, FuseLOX Cervical/Lumba
CapLOX II Pedicle Screw System
TransFasten
TowerLOX Pedicle Screw System, CapLOX II Pedicle Screw System
FuseLOX Lumbar Interbody Fusion System
TirboLOX-C Cervical IBFD
PivoTec, FuseLOX Lumbar Interbody Fusion System
Pivotec
CapLOX II Spinal System
SmartLOX
FuseLOX Cervical IBF
TransFasten - LSF (Lateral Sacroiliac Fusion System)
TirboLOX-L Lumbar IBFD
EquiLOX Expandable Interbody Fusion System
Pivotec, FuseLOX Lumbar Interbody Fusion System, FuseLOX Cervical IBF System
FuseLOX Cervical IBF System
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Complaint File Establishment per 21 CFR 820.198
Repack or Relabel Medical Device