FDA Registration
Active
🇺🇸 United States
PRECISION MEDICAL TECHNOLOGIES
Reg #: 3014273424
·
FEI: 3014273424
·
Expires 2026
Products
19
Proprietary Names
2
Establishment Types
2
Classifications
19
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Registration Details
- Registration Name
- PRECISION MEDICAL TECHNOLOGIES
- Registration Number
- 3014273424
- FEI Number
- 3014273424
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 103 Warrener Drive, --
- City
- Rome City
- State
- IN
- ZIP
- 46784
- Country
- US
Regulatory Submissions
- 510(k) Number
- K130217
Owner / Operator
- Firm Name
- Precision Medical Technologies
- Operator Number
- 9025575
- Address
- 2059 N. POUND DR., --
- City
- Warsaw
- State
- IN
- Postal Code
- 46582
- Country
- US
- Correspondent
- Gregory Neher
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2017-12-12 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-03-21 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2018-12-06 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-05-05 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2015-05-05 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2024-06-11 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2015-05-05 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2015-05-05 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2019-07-08 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2018-01-29 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2017-12-21 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2018-03-26 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2017-12-21 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2016-12-14 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2016-12-14 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2016-12-14 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2016-12-14 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2024-06-11 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-06-17 |
Proprietary Names
ACL system
OIC Variable Angle Small Fragment Locking Plate System
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)
Develop Specifications But Do Not Manufacture At This Facility