Contract manufacturerFLEX-CELL PRECISION, INC. (Lancaster, PA)PennsylvaniaCardiovascularEar, nose and throatGastroenterology and urologyNeurologyOrthopedicGeneral hospitalClass IIClass IIINot classified
FLEX-CELL PRECISION, INC.
Contract manufacturer · Lancaster, PA
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010120135 (openFDA record; or search FDA's registration database)
- FEI number
- 3010120135
- Registered for
- FDA registration year 2027
- Establishment types
- Contract manufacturer
- Owner or operator
- Flex-Cell Precision, Inc. (FDA owner/operator no. 10043308)
- Registered address
- 1151 S Duke St, Lancaster, PA 17602
- Contract listings
- 67 device listings, 39 product codes, first listed Feb 4, 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 |
|---|---|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | Class II | Cardiovascular | Contract manufacturing | Jan 17, 2022 |
| ETN | Stimulator, Nerve | Class II | Ear, nose and throat | Contract manufacturing | Jan 30, 2026 |
| FIP | Subsystem, Water Purification | Class II | Gastroenterology and urology | Contract manufacturing | Jan 17, 2022 |
| HAW | Neurological Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 30, 2020 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 30, 2017 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 30, 2017 |
| JDI | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Cemented | Class II | Orthopedic | Contract manufacturing | Jan 30, 2026 |
| JDO | Device, Fixation, Proximal Femoral, Implant | Class II | Orthopedic | Contract manufacturing | Jan 30, 2026 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | Class II | General hospital | Contract manufacturing | Jan 30, 2026 |
| KWI | Prosthesis, Elbow, Hemi-, Radial, Polymer | Class II | Orthopedic | Contract manufacturing | Jan 12, 2022 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| KWQ | Appliance, Fixation, Spinal Intervertebral Body | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| LPH | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 17, 2025 |
| LWJ | Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 30, 2026 |
| LZO | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 30, 2026 |
| MAX | Intervertebral Fusion Device With Bone Graft, Lumbar | Class II | Orthopedic | Contract manufacturing | Dec 24, 2014 |
| MAY | Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous Cemented, Osteophilic Finish | Class II | Orthopedic | Contract manufacturing | Jan 30, 2026 |
| MBL | Prosthesis, Hip, Semi-Constrained, Uncemented, Metal/Polymer, Porous | Class II | Orthopedic | Contract manufacturing | Jan 17, 2025 |
| MJO | Prosthesis, Intervertebral Disc | Class III | Orthopedic | Contract manufacturing | Jan 30, 2026 |
| MNH | Orthosis, Spondylolisthesis Spinal Fixation | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| MNI | Orthosis, Spinal Pedicle Fixation | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| MQP | Spinal Vertebral Body Replacement Device | Class II | Orthopedic | Contract manufacturing | Dec 24, 2014 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | Class II | Cardiovascular | Contract manufacturing | Jan 17, 2022 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| NKG | Posterior Cervical Screw System | Class II | Orthopedic | Contract manufacturing | Dec 1, 2016 |
| NQP | Posterior Metal/Polymer Spinal System, Fusion | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| NQW | Orthosis, Spine, Plate, Laminoplasty, Metal | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| ODP | Intervertebral Fusion Device With Bone Graft, Cervical | Class II | Orthopedic | Contract manufacturing | Mar 17, 2016 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Dec 1, 2016 |
| OQG | Hip Prosthesis, Semi-Constrained, Cemented, Metal/Polymer, + Additive, Porous, Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 17, 2025 |
| OQH | Hip, Semi-Constrained, Cemented, Metal/Polymer + Additive, Cemented | Class II | Orthopedic | Contract manufacturing | Jan 30, 2026 |
| OQI | Hip, Semi-Constrained, Cemented, Metal/Ceramic/Polymer + Additive, Porous Uncemented | Class II | Orthopedic | Contract manufacturing | Jan 30, 2026 |
| OSH | Pedicle Screw Spinal System, Adolescent Idiopathic Scoliosis | Class II | Orthopedic | Contract manufacturing | Feb 4, 2013 |
| OUR | Sacroiliac Joint Fixation | Class II | Orthopedic | Contract manufacturing | Jan 17, 2022 |
| OVD | Intervertebral Fusion Device With Integrated Fixation, Lumbar | Class II | Orthopedic | Contract manufacturing | Dec 1, 2016 |
| OVE | Intervertebral Fusion Device With Integrated Fixation, Cervical | Class II | Orthopedic | Contract manufacturing | Dec 1, 2016 |
| OWI | Bone Fixation Cerclage, Sublaminar | Class II | Orthopedic | Contract manufacturing | Mar 17, 2016 |
| PEK | Spinous Process Plate | Class II | Orthopedic | Contract manufacturing | Mar 17, 2016 |
| QHP | Vertebral Body Tethering System | Not classified | Orthopedic | Contract manufacturing | Jan 30, 2026 |