Contract manufacturerAMERICAN MANUFACTURING AND ENGINEERING (Montgomeryville, PA)PennsylvaniaNeurologyOrthopedicClass II
AMERICAN MANUFACTURING AND ENGINEERING
Contract manufacturer · Montgomeryville, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010197224 (openFDA record; or search FDA's registration database)
- FEI number
- 3010197224
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- American Manufacturing and Engineering (FDA owner/operator no. 10043997)
- Registered address
- 506 Stump Rd, Montgomeryville, PA 18936
- Contract listings
- 26 device listings, 16 product codes, first listed Apr 16, 2013
- Certification
- Not verified. We have no certification data for this facility yet.
Devices listed as contract work
Each row is an FDA product code this facility lists under its contract establishment type, with the date of its earliest such listing.
| Product code | Device (FDA name) | Class | Category | Role | First listed |
|---|---|---|---|---|---|
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Jan 16, 2023 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 16, 2023 |
| HTN | Washer, Bolt Nut | Class II | Orthopedic | Contract manufacturing | Jan 16, 2023 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Jan 16, 2023 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Apr 16, 2013 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Apr 16, 2013 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Apr 16, 2013 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Apr 16, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Apr 16, 2013 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Jan 16, 2025 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Apr 16, 2013 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Apr 16, 2013 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Jan 16, 2023 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Jan 16, 2023 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Jan 16, 2025 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Jan 16, 2023 |