TURNER MEDICAL INC.

FDA Device Registration & Listing · Athens, AL, US · Registration 3005706667

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
3005706667
FEI Number
3005706667
Entity Name
TURNER MEDICAL INC.
City/State/Country
Athens, AL, US
Establishment Address
130 DURHAM DR, Athens, AL 35611, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Turner Medical Inc. (Owner Number: 10029377)
Owner / Operator Contact Address
89 South Commerce Way, Suite 990, Bethlehem, PA 18017, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

NON-BREAK-OFF PROVISIONAL DRIVER INSERT MLX Graft Containment Plate -14mm 1642466 TRIAL, 22MM 614-130 IMPLANT GUIDE CLIP - PTP 614-131 IMPLANT GUIDE CLIP - LTP Aileron RASP Parallel INST 960-523 BIT GUIDE 3MM-UCD - StealthStation (Drill attachment) INST 960-522 TROCAR - UC DRILL GUIDE-StealthStation -Drill attachment Dyna-Link MIS HINGED COMPRESSOR / DISTRACTOR, SUPPORT TUBE AZE380000

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HTW Bit, Drill Orthopedic Class 1 888.4540 2025-02-03
KCT Sterilization Wrap Containers, Trays, Cassettes & Other Accessories General Hospital Class 2 880.6850 2026-01-13
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-01-07
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-06-02
OWI Bone Fixation Cerclage, Sublaminar Orthopedic Class 2 888.3010 2025-06-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-06-02
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-06-02
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-20
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
PLR Spinal Vertebral Body Replacement Device - Cervical Orthopedic Class 2 888.3060 2025-01-19
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-06-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-06-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-06-02
MQP Spinal Vertebral Body Replacement Device Orthopedic Class 2 888.3060 2025-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
NVM Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon Cardiovascular Class 2 870.1250 2025-01-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-03-03
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-01-21
FSM Tray, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-01-15
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-17
MJO Prosthesis, Intervertebral Disc Unknown Class 3 N/A 2025-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2022-01-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-16
OAS X-Ray, Tomography, Computed, Dental Radiology Class 2 892.1750 2025-01-20
MRW System, Facet Screw Spinal Device Unknown Class U N/A 2022-01-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2026-01-13
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-07-15
KRR Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3540 2020-03-03
NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer Orthopedic Class 2 888.3560 2020-03-03
HRY Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3530 2020-03-03
HSX Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer Orthopedic Class 2 888.3520 2020-03-03
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2019-01-07
OSH Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis Orthopedic Class 2 888.3070 2025-01-16
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-16
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
FZX Guide, Surgical, Instrument General, Plastic Surgery Class 1 878.4800 2025-01-15
HXX Screwdriver Orthopedic Class 1 888.4540 2019-10-22
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-16
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-16
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-16
PEK Spinous Process Plate Orthopedic Class 2 888.3050 2025-01-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-27
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-27
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2025-06-02
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-05-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-05-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-27
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2020-05-14
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2013-04-30
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2013-04-30
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2013-04-30
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2016-04-26
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-03-03
HTR Rasp General, Plastic Surgery Class 1 878.4800 2026-01-13
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-15
NKG Posterior Cervical Screw System Orthopedic Class 2 888.3075 2025-01-15
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-17
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-17
HWA Impactor Orthopedic Class 1 888.4540 2026-03-06
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-27
LXH Orthopedic Manual Surgical Instrument Orthopedic Class 1 888.4540 2009-05-07
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-17
HWE Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment General, Plastic Surgery Class 1 878.4820 2025-06-03
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-05-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-08-26
PHM Intervertebral Fusion Device With Bone Graft, Thoracic Orthopedic Class 2 888.3080 2025-01-20
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-01-20
OUR Sacroiliac Joint Fixation Orthopedic Class 2 888.3040 2022-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2019-10-11
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2019-10-11
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar Orthopedic Class 2 888.3080 2013-04-30
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-06-02
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-06-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2020-03-03
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2024-05-29
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2022-01-27
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2022-01-27
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2025-01-20
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2025-01-20
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2025-01-20
MNI Orthosis, Spinal Pedicle Fixation Orthopedic Class 2 888.3070 2025-01-20
MNH Orthosis, Spondylolisthesis Spinal Fixation Orthopedic Class 2 888.3070 2025-01-20
LLZ System, Image Processing, Radiological Radiology Class 2 892.2050 2025-01-17
GWF Stimulator, Electrical, Evoked Response Neurology Class 2 882.1870 2025-01-17
PDQ Neurosurgical Nerve Locator Ear, Nose, Throat Class 2 874.1820 2025-01-17
JAA System, X-Ray, Fluoroscopic, Image-Intensified Radiology Class 2 892.1650 2025-01-17
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-17
ETN Stimulator, Nerve Ear, Nose, Throat Class 2 874.1820 2025-01-17
OWB Interventional Fluoroscopic X-Ray System Radiology Class 2 892.1650 2025-01-17
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2025-01-17
IKN Electromyograph, Diagnostic Physical Medicine Class 2 890.1375 2025-01-17
MAX Intervertebral Fusion Device With Bone Graft, Lumbar Orthopedic Class 2 888.3080 2025-04-08
ODP Intervertebral Fusion Device With Bone Graft, Cervical Orthopedic Class 2 888.3080 2025-06-02
OVE Intervertebral Fusion Device With Integrated Fixation, Cervical Orthopedic Class 2 888.3080 2025-06-02
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2023-05-10
HBE Drills, Burrs, Trephines & Accessories (Simple, Powered) Neurology Class 2 882.4310 2023-05-10
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2023-05-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2023-05-10
KWQ Appliance, Fixation, Spinal Intervertebral Body Orthopedic Class 2 888.3060 2023-05-10
KWP Appliance, Fixation, Spinal Interlaminal Orthopedic Class 2 888.3050 2022-01-27
HAW Neurological Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27
NKB Thoracolumbosacral Pedicle Screw System Orthopedic Class 2 888.3070 2022-01-27
OLO Orthopedic Stereotaxic Instrument Neurology Class 2 882.4560 2022-01-27

Official Correspondent

Lisa Boyle

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

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

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Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2013 Synthes USA HQ, Inc. 2
MIRS for MATRIX Spine System. Minimally Invasive Reduction Screw (MIRS) for percutaneous instrumentation of the thoracolumbar spine. The Synthes USS are non-cervial spinal fixation devices intended for posterior pedicle screw fixation (T1-S2/ilium), posterior hook fixation (T1-L5), or anterolateral fixation (T8-L5).
Z-0004-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stablization system, Part Number 1156-50.
Z-0005-2008 Abbott Spine 2
PathFinder Bone Drill-Awl-Tap, a part of the PathFinder spinal stabilization system, Part Number 1156-60.
Z-0020-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 45 mm; Catalog number 10-575-PA-45.
Z-0021-06 Pioneer Surgical Technology 2
Pioneer Surgical brand Quantum Spinal Rod System Polyaxial Screw, length 40 mm; Catalog number 10-575-PA-40.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005706667. Last updated year: 2026. Please use registration number 3005706667 when referencing this establishment in official correspondence.
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