FDA Registration
Active
🇺🇸 United States
Acero Precision
Reg #: 3000170817
·
FEI: 3000170817
·
Expires 2026
Products
16
Proprietary Names
29
Establishment Types
1
Classifications
16
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Registration Details
- Registration Name
- Acero Precision
- Registration Number
- 3000170817
- FEI Number
- 3000170817
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1340 Enterprise Drive, Suite 100
- City
- West Chester
- State
- PA
- ZIP
- 19380
- Country
- US
Owner / Operator
- Firm Name
- ACERO PRECISION
- Operator Number
- 9072046
- Address
- 1340 Enterprise Drive, Suite 100
- City
- West Chester
- State
- PA
- Postal Code
- 19380
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2020-02-13 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2020-02-13 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2016-11-22 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2012-12-26 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2015-12-30 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2017-01-30 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2017-01-30 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2017-01-30 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2012-12-26 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2019-11-14 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2018-12-10 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2017-01-26 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2015-12-30 |
| System, Facet Screw Spinal Device | MRW | Class U | Unknown | No | 2014-08-07 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2017-01-26 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2012-12-26 |
Proprietary Names
Simpact
Solstice series screws
Centerline Modular
ProLift Narrow
EOS MIS Interbody Fusion System
TruLift
Intervertebral fusion device with integrated fixation, cervical
ProLift Wedge 8mm
Intervertebral fusion device with bone graft, lumbar
Sochi
Aileron
Intervertebral fusion device with bone graft, cervical
Sentry
Sochi OCT
ProLift Micro
Monaco Uni-Planar
Brickyard (Indy) Standalone
Arx Modular
Intervertebral Fusion Device with bone graft, lumbar
OVE - Intervertebral fusion device with integrated fixation, cervical
Arx
Interbody fusion system
MAX - Intervertebral fusion device with bone graft, lumbar OVD - Intervertebral fusion device with integrated fixation, lumbar
Lynx
ProLift Wedge
ProLift Lateral Fixated
Appliance, fixation, spinal intervertebral body
Arx Illiac
Prolift Lateral
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)