FDA Registration
Active
🇺🇸 United States
FLEX-CELL PRECISION, INC.
Reg #: 3010120135
·
FEI: 3010120135
·
Expires 2026
Products
39
Proprietary Names
1
Establishment Types
1
Classifications
39
Registration Details
- Registration Name
- FLEX-CELL PRECISION, INC.
- Registration Number
- 3010120135
- FEI Number
- 3010120135
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1151 S Duke St
- City
- Lancaster
- State
- PA
- ZIP
- 17602
- Country
- US
Owner / Operator
- Firm Name
- Flex-Cell Precision, Inc.
- Operator Number
- 10043308
- Address
- 1151 South Duke Street
- City
- Lancaster
- State
- PA
- Postal Code
- 17602
- Country
- US
- Correspondent
- Anthony Fanning
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2022-01-12 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2022-01-12 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2022-01-12 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2022-01-12 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2022-01-12 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2022-01-12 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | LPH | Class 2 | Orthopedic | No | 2025-01-17 |
| Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | MBL | Class 2 | Orthopedic | No | 2025-01-17 |
| Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | OQG | Class 2 | Orthopedic | No | 2025-01-17 |
| Neurological Stereotaxic Instrument | HAW | Class 2 | Neurology | No | 2022-01-17 |
| Prosthesis, Elbow, Hemi-, Radial, Polymer | KWI | Class 2 | Orthopedic | No | 2022-01-12 |
| Vertebral Body Tethering System | QHP | Class N | Unknown | No | 2026-01-30 |
| Orthosis, Spine, Plate, Laminoplasty, Metal | NQW | Class 2 | Orthopedic | No | 2017-11-30 |
| Bone Fixation Cerclage, Sublaminar | OWI | Class 2 | Orthopedic | No | 2016-03-17 |
| Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | OSH | Class 2 | Orthopedic | No | 2016-03-17 |
| Spinous Process Plate | PEK | Class 2 | Orthopedic | No | 2016-03-17 |
| Prosthesis, Intervertebral Disc | MJO | Class 3 | Unknown | No | 2026-01-30 |
| Subsystem, Water Purification | FIP | Class 2 | Gastroenterology, Urology | No | 2022-01-17 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2016-03-17 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | Class 2 | Orthopedic | No | 2021-04-30 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-02-07 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-02-07 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | Class 2 | General Hospital | No | 2026-01-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | LZO | Class 2 | Orthopedic | No | 2026-01-30 |
| Sacroiliac Joint Fixation | OUR | Class 2 | Orthopedic | No | 2022-01-17 |
| Device, Fixation, Proximal Femoral, Implant | JDO | Class 2 | Orthopedic | No | 2026-01-30 |
| Posterior Metal/Polymer Spinal System, Fusion | NQP | Class 2 | Orthopedic | No | 2013-02-04 |
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2022-01-17 |
| Stimulator, Nerve | ETN | Class 2 | Ear, Nose, Throat | No | 2026-01-30 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2016-12-01 |
| Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | MAY | Class 2 | Orthopedic | No | 2026-01-30 |
| Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | OQI | Class 2 | Orthopedic | No | 2026-01-30 |
| Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | OQH | Class 2 | Orthopedic | No | 2026-01-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | JDI | Class 2 | Orthopedic | No | 2026-01-30 |
| Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | LWJ | Class 2 | Orthopedic | No | 2026-01-30 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2014-12-24 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2022-01-17 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | Class 2 | Orthopedic | No | 2016-12-01 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | Class 2 | Orthopedic | No | 2016-12-01 |
Proprietary Names
ODP - Intervertebral fusion device with bone graft, cervical
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)