Contract manufacturerMedartis Inc. (Warsaw, IN)IndianaGeneral and plastic surgeryOrthopedicClass IClass II
Medartis Inc.
Contract manufacturer ยท Warsaw, IN
FDA-registered (openFDA, export of Oct 21, 2026) ISO 13485: not verified
- FDA registration
- 3009540749 (openFDA record; or search FDA's registration database)
- FEI number
- 3009540749
- Registered for
- FDA registration year 2026
- Establishment types
- Complaint file establishment; Specification developer; Manufacturer; Contract manufacturer; Repackager or relabeler
- Owner or operator
- MEDARTIS AG (FDA owner/operator no. 9033581)
- Registered address
- 1195 Polk Drive, Warsaw, IN 46582
- Contract listings
- 31 device listings, 30 product codes, first listed Apr 15, 1998
- 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 |
|---|---|---|---|---|---|
| FSM | Tray, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Dec 5, 2012 |
| FTY | Tape, Measuring, Rulers And Calipers | Class I | General and plastic surgery | Contract manufacturing | Nov 5, 2024 |
| FZO | Chisel, Surgical, Manual | Class I | General and plastic surgery | Contract manufacturing | Nov 5, 2024 |
| FZX | Guide, Surgical, Instrument | Class I | General and plastic surgery | Contract manufacturing | Nov 5, 2024 |
| GAD | Retractor | Class I | General and plastic surgery | Contract manufacturing | Nov 5, 2024 |
| GAH | Stylet, Surgical, General & Plastic Surgery | Class I | General and plastic surgery | Contract manufacturing | Nov 5, 2024 |
| GFC | Driver, Surgical, Pin | Class I | General and plastic surgery | Contract manufacturing | May 3, 2023 |
| GFG | Bit, Surgical | Class I | General and plastic surgery | Contract manufacturing | Nov 5, 2024 |
| HRS | Plate, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HSB | Rod, Fixation, Intramedullary And Accessories | Class II | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HTH | Protractor | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HTJ | Gauge, Depth | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HTY | Pin, Fixation, Smooth | Class II | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HWA | Impactor | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HWB | Extractor | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HWC | Screw, Fixation, Bone | Class II | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HWJ | Awl | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HWM | Osteotome | Class I | General and plastic surgery | Contract manufacturing | Nov 5, 2024 |
| HWQ | Passer | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HWX | Tap, Bone | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HXB | Probe | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HXD | Clamp | Class I | General and plastic surgery | Contract manufacturing | Nov 5, 2024 |
| HXL | Mallet | Class I | General and plastic surgery | Contract manufacturing | Nov 5, 2024 |
| HXP | Instrument, Bending Or Contouring | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HXW | Bender | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| HXX | Screwdriver | Class I | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| KIK | Hook, Bone | Class I | General and plastic surgery | Contract manufacturing | Nov 5, 2024 |
| KWP | Appliance, Fixation, Spinal Interlaminal | Class II | Orthopedic | Contract manufacturing | Nov 5, 2024 |
| LXH | Orthopedic Manual Surgical Instrument | Class I | Orthopedic | Contract manufacturing | Apr 15, 1998 |
| NKB | Thoracolumbosacral Pedicle Screw System | Class II | Orthopedic | Contract manufacturing | Nov 5, 2024 |