FDA Registration
Active
🇺🇸 United States
FLOSPINE LLC
Reg #: 3011513267
·
FEI: 3011513267
·
Expires 2026
Products
30
Proprietary Names
7
Establishment Types
1
Classifications
30
Registration Details
- Registration Name
- FLOSPINE LLC
- Registration Number
- 3011513267
- FEI Number
- 3011513267
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3998 FAU Blvd, Suite 300
- City
- Boca Raton
- State
- FL
- ZIP
- 33431
- Country
- US
Regulatory Submissions
- 510(k) Number
- K223231
Owner / Operator
- Firm Name
- FloSpine LLC
- Operator Number
- 10048786
- Address
- 3998 FAU Blvd, Suite 300
- City
- Boca Raton
- State
- FL
- Postal Code
- 33431
- Country
- US
- Correspondent
- Waldi L Harris
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2016-12-20 |
| Accessories, Fixation, Spinal Intervertebral Body | LYQ | Class 1 | Orthopedic | No | 2025-02-03 |
| Bender | HXW | Class 1 | Orthopedic | No | 2016-12-20 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-02-03 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2016-12-20 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2021-08-19 |
| Caliper | KTZ | Class 1 | Orthopedic | No | 2016-12-20 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2016-12-20 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2025-02-03 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2021-09-23 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2025-02-03 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2016-12-20 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2025-02-04 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2016-12-20 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2016-12-20 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2025-02-03 |
| Instrument, Cutting, Orthopedic | HTZ | Class 1 | General, Plastic Surgery | No | 2016-12-20 |
| Awl | HWJ | Class 1 | Orthopedic | No | 2016-12-20 |
| File | HTP | Class 1 | Orthopedic | No | 2025-02-03 |
| Probe | HXB | Class 1 | Orthopedic | No | 2016-12-20 |
| Instrument, Bending Or Contouring | HXP | Class 1 | Orthopedic | No | 2016-12-20 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2016-12-20 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2016-12-20 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2015-02-27 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-02-27 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2015-02-27 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2015-02-27 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2015-02-27 |
Proprietary Names
Canaveral Pedicle Screw System
Ti-Largo
Panama Anterior Cervical Plate System
Panama Anterior Cervical Plate System
KeyLift Expandable Interlaminar Stabilization System
Canaveral Minimally Invasive Screw System
Canaveral Deformity Screw System
Establishment Types
Manufacture Medical Device