FDA Registration
Active
🇺🇸 United States
STRUCTURE MEDICAL, LLC.
Reg #: 3006783837
·
FEI: 3009322142
·
Expires 2026
Products
45
Proprietary Names
28
Establishment Types
1
Classifications
45
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Registration Details
- Registration Name
- STRUCTURE MEDICAL, LLC.
- Registration Number
- 3006783837
- FEI Number
- 3009322142
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 9935 Business Circle
- City
- Naples
- State
- FL
- ZIP
- 34112
- Country
- US
Owner / Operator
- Firm Name
- Structure Medical, LLC.
- Operator Number
- 10042434
- Address
- 9935 Business Circle
- City
- Naples
- State
- FL
- Postal Code
- 34112
- Country
- US
- Correspondent
- Tejash Naik
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2020-03-25 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2020-03-25 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2020-03-25 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2020-03-25 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-03-25 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2020-03-25 |
| Pin, Fixation, Threaded | JDW | Class 2 | Orthopedic | No | 2020-03-25 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2020-03-25 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2024-12-09 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2024-12-09 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-12-09 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2024-12-09 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-12-09 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-12-09 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2026-02-01 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2026-02-01 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2026-02-01 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-01-15 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-01-15 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2026-02-01 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2014-07-25 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | Class 2 | Orthopedic | No | 2013-01-15 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2026-02-01 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2026-02-01 |
| Prosthesis, Wrist, Carpal Trapezium | KYI | Class 2 | Orthopedic | No | 2013-01-16 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-02-01 |
| Nail, Fixation, Bone | JDS | Class 2 | Orthopedic | No | 2026-02-01 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2024-12-09 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-01-16 |
| Prosthesis, Spinous Process Spacer/Plate | NQO | Class 3 | Unknown | No | 2019-03-30 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2026-02-01 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-01-16 |
| Internal Hinged Elbow Fixator | OZI | Class 2 | Orthopedic | No | 2019-08-09 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2020-09-03 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2026-01-30 |
| Template | HWT | Class 1 | Orthopedic | No | 2012-11-27 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-12-29 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2026-02-01 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2026-02-01 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2026-02-01 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2026-02-01 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2026-02-01 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2020-03-25 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2013-02-01 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2013-02-01 |
Proprietary Names
A.L.P.S. ELBOW SYSTEMDISTAL HUMERAL LATERAL PLATE
DISTAL HUMERAL LATERAL PLATE
DISTAL HUMERAL MEDIAL PLATE
A.L.P.S. ELBOW SYSTEM OLECRANON PLATE
F³ FRAGMENT PLATING SYSTEMSMALL FRAG LOCKING PLATE
OLECRANON PLATE
LOW PROFILE CORTICAL WASHER
CORONOID PLATE
A.L.P.S. ELBOW SYSTEM DISTAL HUMERAL MEDIAL PLATE
PROXIMAL RADIUS PLATE
A.L.P.S. ELBOW SYSTEMDISTAL HUMERAL POSTERIOR LATERAL PLATE
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
Gen II Cannulated Screws
DISTAL VOLAR RADIUS PLATING SYSTEMS
Response 5.5 Spine System
A.L.P.S. Clavicle Plating System
Caliber Spacers
DISTAL RADIUS VOLAR RIM PLATE STANDARD, DISTAL RADIUS VOLAR RIM PLATE NARROW
Internal Joint Stabilizer - Elbow
Reduction Spin Knob
Set Screw, Large
K121349
Distal Elbow Plating System
Fragment Plate System
Distal Humerus Plating System
MODIFIED DISTAL RADIUS PLATING SYSTEM
Persona Partial Knee System
A.L.P.S.1ST MTP FUSION PLATE LARGE
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)