FDA Registration
Active
🇺🇸 United States
PRECISION MEDICAL TECHNOLOGIES
Reg #: 1835296
·
FEI: 3000210784
·
Expires 2026
Products
28
Proprietary Names
6
Establishment Types
2
Classifications
28
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Registration Details
- Registration Name
- PRECISION MEDICAL TECHNOLOGIES
- Registration Number
- 1835296
- FEI Number
- 3000210784
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 2059 N. POUND DR.
- City
- WARSAW
- State
- IN
- ZIP
- 46582
- 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 |
|---|---|---|---|---|---|
| Probe | HXB | Class 1 | Orthopedic | No | 2024-06-24 |
| Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | KTT | Class 2 | Orthopedic | No | 2017-12-21 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2017-12-21 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2013-02-12 |
| Rod, Fixation, Intramedullary And Accessories | HSB | Class 2 | Orthopedic | No | 2024-11-04 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2013-02-13 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2013-02-13 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2024-04-01 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-02-13 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-02-13 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2013-02-13 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2018-01-29 |
| Staple, Fixation, Bone | JDR | Class 2 | Orthopedic | No | 2018-01-29 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | Class 2 | Orthopedic | No | 2018-03-26 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2024-11-04 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2019-05-28 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 2013-02-08 |
| Cerclage, Fixation | JDQ | Class 2 | Orthopedic | No | 2013-02-13 |
| Washer, Bolt Nut | HTN | Class 2 | Orthopedic | No | 2015-01-08 |
| Wrench | HXC | Class 1 | Orthopedic | No | 2019-03-21 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2013-02-13 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-06-17 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-02-13 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2013-02-13 |
| Driver, Surgical, Pin | GFC | Class 1 | General, Plastic Surgery | No | 2024-03-07 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2024-11-04 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2013-02-08 |
| Instrument, Surgical, Orthopedic, Dc-Powered Motor And Accessory/Attachment | KIJ | Class 1 | General, Plastic Surgery | No | 2024-06-24 |
Proprietary Names
ACL system
5.5 CLOSED VERTEGLIDE PEDICLE SCREW DRIVER
5.5 OPEN VERTEGLIDE PEDICLE SCREW DRIVER
4.5 OPEN VERTEGLIDE PEDICLE SCREW DRIVER
4.5 CLOSED VERTEGLIDE PEDICLE SCREW DRIVER
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