FDA Registration
Active
🇺🇸 United States
Structure Medical, LLC.
Reg #: 3007993775
·
FEI: 3007993775
·
Expires 2026
Products
43
Proprietary Names
40
Establishment Types
1
Classifications
43
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Registration Details
- Registration Name
- Structure Medical, LLC.
- Registration Number
- 3007993775
- FEI Number
- 3007993775
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 111 Cayuga Dr.
- City
- Mooresville
- State
- NC
- ZIP
- 28117
- 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 |
|---|---|---|---|---|---|
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2014-07-25 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2014-07-25 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-01-15 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-01-15 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-04-03 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2013-02-01 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-10-08 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2013-01-16 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2013-01-16 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2013-01-15 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-12-09 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2018-12-29 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2014-07-25 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2014-07-25 |
| Bit, Surgical | GFG | Class 1 | General, Plastic Surgery | No | 2025-01-31 |
| Arthroscope | HRX | Class 2 | Orthopedic | No | 2024-12-09 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-01-15 |
| Bone Cement, Posterior Screw Augmentation | PML | Class 2 | Orthopedic | No | 2024-12-09 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2026-06-09 |
| Instrument, Compression | HWN | Class 1 | Orthopedic | No | 2020-09-03 |
| Prosthesis, Wrist, Carpal Trapezium | KYI | Class 2 | Orthopedic | No | 2013-01-16 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2024-12-09 |
| Plate, Bone, Growth Control, Pediatric, Epiphysiodesis | OBT | Class 2 | Orthopedic | No | 2013-01-15 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2026-02-01 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite | LXT | Class 2 | Orthopedic | No | 2013-01-16 |
| 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 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2014-07-25 |
| 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 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2024-12-09 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2025-01-31 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2025-01-31 |
| Internal Hinged Elbow Fixator | OZI | Class 2 | Orthopedic | No | 2019-08-09 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | Class 2 | Orthopedic | No | 2024-12-09 |
| Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented | KWT | Class 2 | Orthopedic | No | 2024-12-09 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented | MBF | Class 2 | Orthopedic | No | 2024-12-09 |
| Prosthesis, Elbow, Constrained, Cemented | JDC | Class 2 | Orthopedic | No | 2024-12-09 |
| Pin, Fixation, Smooth | HTY | 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 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2025-01-31 |
Proprietary Names
Response 5.5 Spine System
A.L.P.S.1ST MTP FUSION PLATE LARGE
Plating System
ROSA Knee System
Reduction Spin Knob
Bit, Surgical
Endoscopic Carpal Tunnel Instrument
Caliber Spacers
DVR DORSAL PLATE, DVR LATERAL PLATE, DVR ULNA PLATE
Protean Fragment Plating System
ROSA® Shoulder System
Michelangelo Bunion System
Rosa Shoulder System
CMC Cable Fix
Distal Elbow Plating System
Variable Pitch Compression Screw System
Pediplate
Persona Partial Knee System
Fragment Plate System
Endoscopic Mortons Neuroma Instrument
Response Spine System
Tap, Bone
Guide, surgical, instrument
Altera Spacer
Sub-Taylor Lok, Model 7-11mm
Endotrak System
Internal Joint Stabilizer - Elbow
Segmental Revision System (SRS)
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
Extractor
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)