Contract manufacturerPMC SMART Solutions, LLC (Shelbyville, IN)IndianaGeneral hospitalGeneral and plastic surgeryNeurologyOrthopedicGastroenterology and urologyClass IIClass IUnclassified
PMC SMART Solutions, LLC
Contract manufacturer · Shelbyville, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3010408671 (openFDA record; or search FDA's registration database)
- FEI number
- 3010408671
- Registered for
- FDA registration year 2026
- Establishment types
- Contract manufacturer
- Owner or operator
- PMC SMART Solutions (FDA owner/operator no. 10044542)
- Registered address
- 1451 S. Miller Avenue, Shelbyville, IN 46176
- Contract listings
- 14 device listings, 13 product codes, first listed Jun 25, 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 |
|---|---|---|---|---|---|
| BYZ | Trap, Sterile Specimen | Class II | General hospital | Contract manufacturing | Jul 31, 2020 |
| FSZ | Light, Surgical, Carrier | Class II | General and plastic surgery | Contract manufacturing | May 28, 2026 |
| FZP | Clip, Implantable | Class II | General and plastic surgery | Contract manufacturing | Feb 18, 2025 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Nov 30, 2020 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Apr 15, 2021 |
| HBO | Clip, Scalp | Class II | Neurology | Contract manufacturing | Aug 4, 2016 |
| HTW | Bit, Drill | Class I | Orthopedic | Contract manufacturing | Nov 30, 2020 |
| JXG | Shunt, Central Nervous System And Components | Class II | Neurology | Contract manufacturing | May 18, 2018 |
| LFL | Instrument, Ultrasonic Surgical | Unclassified | General and plastic surgery | Contract manufacturing | Feb 11, 2020 |
| NTB | System, Ablation, Ultrasound And Accessories | Class II | General and plastic surgery | Contract manufacturing | Jul 25, 2013 |
| ODC | Endoscope Channel Accessory | Class II | Gastroenterology and urology | Contract manufacturing | Apr 9, 2019 |
| OLO | Orthopedic Stereotaxic Instrument | Class II | Neurology | Contract manufacturing | Jun 25, 2013 |
| SCV | Modular Electromechanical Surgical System | Class II | General and plastic surgery | Contract manufacturing | Jan 5, 2026 |