FDA Registration
Active
🇺🇸 United States
TURNER MEDICAL INC.
Reg #: 3005706667
·
FEI: 3005706667
·
Expires 2026
Products
45
Proprietary Names
13
Establishment Types
2
Classifications
45
Registration Details
- Registration Name
- TURNER MEDICAL INC.
- Registration Number
- 3005706667
- FEI Number
- 3005706667
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 130 DURHAM DR
- City
- Athens
- State
- AL
- ZIP
- 35611
- Country
- US
Owner / Operator
- Firm Name
- Turner Medical Inc.
- Operator Number
- 10029377
- Address
- 89 South Commerce Way, Suite 990
- City
- Bethlehem
- State
- PA
- Postal Code
- 18017
- Country
- US
- Correspondent
- Lisa Boyle
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2025-02-03 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2026-01-13 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2025-01-20 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2025-01-20 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2025-01-20 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2025-01-20 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2025-01-20 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-01-07 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2025-06-02 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2025-06-02 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2025-01-20 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2022-01-27 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2025-01-19 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2025-01-20 |
| Catheter, Angioplasty, Peripheral, Transluminal, Dual-Balloon | NVM | Class 2 | Cardiovascular | No | 2025-01-15 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2025-01-15 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2025-01-20 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2022-01-27 |
| X-Ray, Tomography, Computed, Dental | OAS | Class 2 | Radiology | No | 2025-01-20 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2022-01-27 |
| Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer | KRR | Class 2 | Orthopedic | No | 2020-03-03 |
| Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | NPJ | Class 2 | Orthopedic | No | 2020-03-03 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | Class 2 | Orthopedic | No | 2020-03-03 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | Class 2 | Orthopedic | No | 2020-03-03 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2025-01-16 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2025-01-15 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2019-10-22 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2025-01-20 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2026-01-13 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2025-01-15 |
| Intervertebral Fusion Device With Bone Graft, Thoracic | PHM | Class 2 | Orthopedic | No | 2025-01-17 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2026-03-06 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2009-05-07 |
| Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment | HWE | Class 1 | General, Plastic Surgery | No | 2025-06-03 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2022-01-27 |
| System, Image Processing, Radiological | LLZ | Class 2 | Radiology | No | 2025-01-17 |
| Stimulator, Electrical, Evoked Response | GWF | Class 2 | Neurology | No | 2025-01-17 |
| Neurosurgical Nerve Locator | PDQ | Class 2 | Ear, Nose, Throat | No | 2025-01-17 |
| System, X-Ray, Fluoroscopic, Image-Intensified | JAA | Class 2 | Radiology | No | 2025-01-17 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2025-01-17 |
| Interventional Fluoroscopic X-Ray System | OWB | Class 2 | Radiology | No | 2025-01-17 |
| Electromyograph, Diagnostic | IKN | Class 2 | Physical Medicine | No | 2025-01-17 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2025-06-02 |
| Drills, Burrs, Trephines & Accessories (Simple, Powered) | HBE | Class 2 | Neurology | No | 2023-05-10 |
| Face Plate Hearing Aid | LRB | Class 1 | Ear, Nose, Throat | No | 2025-01-16 |
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
Affix II S Bladed Plate - Dimensions 40mm 7579040
RG Modulex
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Manufacture Device in the United States for Export Only