FDA Registration
Active
🇺🇸 United States
ORTHO-MED, INC.
Reg #: 3019455
·
FEI: 3019455
·
Expires 2026
Products
61
Proprietary Names
6
Establishment Types
1
Classifications
61
Registration Details
- Registration Name
- ORTHO-MED, INC.
- Registration Number
- 3019455
- FEI Number
- 3019455
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 14875 SW 72nd Ave
- City
- Tigard
- State
- OR
- ZIP
- 97224
- Country
- US
Regulatory Submissions
- 510(k) Number
- K102845
Owner / Operator
- Firm Name
- ORTHO-MED, INC.
- Operator Number
- 3019455
- Address
- 14875 SW 72nd Ave, --
- City
- Tigard
- State
- OR
- Postal Code
- 97224
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Knife, Amputation | GDN | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Osteotome, Manual | GFI | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 2019-12-18 |
| Hammer, Surgical | FZY | Class 1 | General, Plastic Surgery | No | 2022-08-31 |
| Pinwheel | GWY | Class 1 | Neurology | No | 2022-08-31 |
| Impactor | HWA | Class 1 | Orthopedic | No | 2019-12-18 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2026-06-17 |
| Hook, Bone | KIK | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| File, Surgical, General & Plastic Surgery | GEO | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2022-08-31 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2024-12-16 |
| Clamp | HXD | Class 1 | General, Plastic Surgery | No | 2024-02-26 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Mallet | HXL | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Passer, Wire, Orthopedic | HXI | Class 1 | Orthopedic | No | 2019-12-18 |
| Instruments, Surgical, Cardiovascular | DWS | Class 1 | Cardiovascular | No | 2008-05-01 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2026-04-16 |
| Tape, Measuring, Rulers And Calipers | FTY | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Osteotome | HWM | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Curette | HTF | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Screwdriver, Surgical | LRZ | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Punch, Surgical | LRY | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Chisel, Bone, Surgical | EML | Class 1 | Dental | No | 2019-12-18 |
| Instrument, Manual, Surgical, General Use | MDM | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Cutter, Surgical | FZT | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Forceps, Wire Holding | HYA | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Tray, Surgical, Needle | FSH | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Scissors, Orthopedic, Surgical | HRR | Class 1 | Orthopedic | No | 2019-12-18 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 2019-12-18 |
| Cutter, Wire | HXZ | Class 1 | Orthopedic | No | 2019-12-18 |
| Tamp | HXG | Class 1 | Orthopedic | No | 2019-12-18 |
| Chisel (Osteotome) | KDG | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 2026-06-16 |
| Forceps, General & Plastic Surgery | GEN | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Pliers, Surgical | HTC | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Cannula, Surgical, General & Plastic Surgery | GEA | Class 1 | General, Plastic Surgery | No | 2022-08-31 |
| Trephine | HWK | Class 1 | Orthopedic | No | 2019-12-18 |
| Forceps, Rongeur, Surgical | EMH | Class 1 | Dental | No | 2019-12-18 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 2018-08-02 |
| Stripper, Surgical | HRT | Class 1 | Orthopedic | No | 2026-06-16 |
| Countersink | HWW | Class 1 | Orthopedic | No | 2019-12-18 |
| Extractor | HWB | Class 1 | Orthopedic | No | 2022-08-31 |
| Rasp | HTR | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Mallet, Surgical, General & Plastic Surgery | GFJ | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Retractor, Self-Retaining | FFO | Class 1 | Gastroenterology, Urology | No | 2019-12-18 |
| Handle, Scalpel | GDZ | Class 1 | General, Plastic Surgery | No | 2022-08-31 |
| Elevator | HTE | Class 1 | General, Plastic Surgery | No | 2019-12-18 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2019-12-18 |
| Bender | HXW | Class 1 | Orthopedic | No | 2026-04-16 |
| Pin, Fixation, Smooth | HTY | Class 2 | Orthopedic | No | 2019-04-10 |
| Screw, Fixation, Bone | HWC | Class 2 | Orthopedic | No | 2019-04-10 |
| Plate, Fixation, Bone | HRS | Class 2 | Orthopedic | No | 2019-04-10 |
| Brush, Scrub, Operating-Room | GEC | Class 1 | General, Plastic Surgery | No | 2022-08-31 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2026-06-17 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 2019-12-18 |
| Tap, Bone | HWX | Class 1 | Orthopedic | No | 2019-12-18 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 2008-05-01 |
| Ring Cutter | FNS | Class 1 | General Hospital | No | 2022-08-31 |
| Retractor, Non-Self-Retaining | FGN | Class 1 | Gastroenterology, Urology | No | 2019-12-18 |
Proprietary Names
ORTHOMED INC
Ortho-Med Inc
Orthomed, Inc.
Orthomed
Orthomed Rongeurs
Orthomed Kwire
Establishment Types
Repack or Relabel Medical Device