Structure Medical, LLC.

FDA Device Registration & Listing · Mooresville, NC, US · Registration 3007993775

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007993775
FEI Number
3007993775
Entity Name
Structure Medical, LLC.
City/State/Country
Mooresville, NC, US
Establishment Address
111 Cayuga Dr., Mooresville, NC 28117, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Structure Medical, LLC. (Owner Number: 10042434)
Owner / Operator Contact Address
9935 Business Circle, Naples, FL 34112, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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 Reduction Spin Knob 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2014-07-25
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2014-07-25
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2015-12-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-15
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-04-03
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2013-02-01
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-10-08
KWI Prosthesis, Elbow, Hemi-, Radial, Polymer Orthopedic Class 2 888.3170 2013-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-16
NQW Orthosis, Spine, Plate, Laminoplasty, Metal Orthopedic Class 2 888.3050 2013-01-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2020-03-25
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-09
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2018-12-29
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-15
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2014-07-25
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2014-07-25
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-16
GFG Bit, Surgical General, Plastic Surgery Class 1 878.4820 2025-01-31
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-15
HRX Arthroscope Orthopedic Class 2 888.1100 2024-12-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-08-09
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2024-12-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-07-25
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-15
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-12-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-12-09
PML Bone Cement, Posterior Screw Augmentation Orthopedic Class 2 888.3027 2024-12-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-11-18
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-11-18
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2026-06-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-06-09
HWN Instrument, Compression Orthopedic Class 1 888.4540 2020-09-03
KYI Prosthesis, Wrist, Carpal Trapezium Orthopedic Class 2 888.3770 2013-01-16
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-12-09
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2013-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-15
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2024-12-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-12-09
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-16
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-15
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2013-01-15
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-15
HTN Washer, Bolt Nut Orthopedic Class 2 888.3030 2024-12-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2026-02-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-15
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-08-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-08-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-15
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2013-01-16
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2024-12-09
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2024-12-09
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2024-12-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-16
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-02-01
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2026-02-01
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-10-08
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-08
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-15
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-16
LXT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, Metal Composite Orthopedic Class 2 888.3030 2013-01-16
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-15
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2013-01-16
OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis Orthopedic Class 2 888.3030 2013-01-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-15
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2020-03-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2021-07-13
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-08-09
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2019-10-08
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-07-25
MBI Fastener, Fixation, Nondegradable, Soft Tissue Orthopedic Class 2 888.3040 2013-02-01
JDR Staple, Fixation, Bone Orthopedic Class 2 888.3030 2013-02-01
JDO Device, Fixation, Proximal Femoral, Implant Orthopedic Class 2 888.3030 2014-07-25
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component Orthopedic Class 2 888.3030 2014-07-25
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-07-03
HRX Arthroscope Orthopedic Class 2 888.1100 2024-12-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2024-12-09
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2024-12-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-12-09
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-12-09
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2024-12-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2024-12-09
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-15
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2014-07-25
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2013-01-15
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2024-12-09
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2024-12-09
HWX Tap, Bone Orthopedic Class 1 888.4540 2025-01-31
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-01-31
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2019-08-09
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2026-02-01
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2026-02-01
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2026-02-01
HWC Screw, Fixation, Bone Orthopedic Class 2 888.3040 2013-01-16
HRS Plate, Fixation, Bone Orthopedic Class 2 888.3030 2013-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2013-01-16

Official Correspondent

Tejash Naik

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Structure Medical, LLC.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3006783837 STRUCTURE MEDICAL, LLC. Naples, FL, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K192492 Astura Medical, LLC EL CAPITAN Anterior Lumber Interbody System 2020-04-21
K212498 Nexus Spine, LLC Stable-L Standalone Lumbar Interbody System 2022-03-18
K041888 Signus Medizintechnik GmbH CURVED PEEK TETRIS SPINAL IMPLANT 2004-08-10
K211892 Arftx Medical, LLC ArtFx Corpectomy Cages (Espinax and Distractania Corpectomy Cages) 2022-10-06
K070082 Vertebration,Inc XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY 2007-04-20

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0036-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System VARIABLE ANGLE SCREW MODULE, REF 176-503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0037-2013 Medtronic Sofamor Danek USA Inc 2
ATLANTIS(R) Anterior Cervical Plate System FIXED ANGLE SCREW MODULE, REF 176-504, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0038-2013 Medtronic Sofamor Danek USA Inc 2
PREMIER(R) Anterior Cervical Plate System SCREW BLOCK, REF 1860503, QTY: 1 EA, Rx only, Medtronic Sofamore Danek USA, Inc., 1800 Pyramid Place, Memphis, Tennessee 38132. Orthopedic. This instrument is a precision device which may incorporate a measuring function and has uses as described on the label. Unless labeled for single use, this instrument may be re-used.
Z-0040-05 Zimmer Spine, Inc. 2
ATO Drill Guide Kit (All Through One Drill Guides Set), model number 07.00860.001, product is packaged in trays.
Z-0026-2011 Zimmer Inc. 2
SpeedLink 5.5 Transverse Connector Short 39.5-44mm, non-sterile, 1302-55S

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007993775. Last updated year: 2026. Please use registration number 3007993775 when referencing this establishment in official correspondence.
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