Data / Medical devices / United States / Ortho-Med, Inc.
Ortho-Med, Inc.: FDA-registered device maker in Tigard, OR, United States, 1 510(k) clearance
Ortho-Med, Inc. is registered with the FDA (registration 3019455) in Tigard, OR, United States. It lists 62 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 13, 2011. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3019455
- Address
- 14875 SW 72nd Ave, Tigard, OR, United States, 97224
- Owner or operator
- ORTHO-MED, INC. (3019455)
- Roles
- Repackager or relabeler
- First device listed
- May 1, 2008
- Registered through
- 2027
- Brand names listed
- ORTHOMED INC, Ortho-Med Inc, Orthomed, Orthomed Kwire, Orthomed Rongeurs, Orthomed, Inc.
Devices it lists
| Device | Product code | Class | Role | Source |
|---|
| Awl | HWJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bender | HXW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Bit, Drill | HTW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Brush, Scrub, Operating-Room | GEC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel (Osteotome) | KDG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Chisel, Bone, Surgical | EML | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp | HXD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Countersink | HWW | 1 | Repackager or relabeler | accessdata.fda.gov |
| Curette | HTF | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cutter, Surgical | FZT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Elevator | HTE | 1 | Repackager or relabeler | accessdata.fda.gov |
| Extractor | HWB | 1 | Repackager or relabeler | accessdata.fda.gov |
| File, Surgical, General & Plastic Surgery | GEO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, General & Plastic Surgery | GEN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Rongeur, Surgical | EMH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Forceps, Wire Holding | HYA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Gouge, Surgical, General & Plastic Surgery | GDH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hammer, Surgical | FZY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Handle, Scalpel | GDZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Holder, Needle; Orthopedic | HXK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Bone | KIK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Impactor | HWA | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instrument, Manual, Surgical, General Use | MDM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Knife, Amputation | GDN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mallet | HXL | 1 | Repackager or relabeler | accessdata.fda.gov |
| Mallet, Surgical, General & Plastic Surgery | GFJ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Osteotome | HWM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Osteotome, Manual | GFI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Passer, Wire, Orthopedic | HXI | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pinwheel | GWY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Pliers, Surgical | HTC | 1 | Repackager or relabeler | accessdata.fda.gov |
| Punch, Surgical | LRY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rasp | HTR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Reamer | HTO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor | GAD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Non-Self-Retaining | FGN | 1 | Repackager or relabeler | accessdata.fda.gov |
| Retractor, Self-Retaining | FFO | 1 | Repackager or relabeler | accessdata.fda.gov |
| Ring Cutter | FNS | 1 | Repackager or relabeler | accessdata.fda.gov |
| Rongeur | HTX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Scissors, Orthopedic, Surgical | HRR | 1 | Repackager or relabeler | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Repackager or relabeler | accessdata.fda.gov |
| Screwdriver, Surgical | LRZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stripper, Surgical | HRT | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tamp | HXG | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tape, Measuring, Rulers And Calipers | FTY | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical | LRP | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Needle | FSH | 1 | Repackager or relabeler | accessdata.fda.gov |
| Trephine | HWK | 1 | Repackager or relabeler | accessdata.fda.gov |
| Twister, Wire | HXS | 1 | Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|
| May 13, 2011 | K102845 | MAHE FIXATION PLATE AND SCREW SYSTEM | HRS | Substantially Equivalent | Mahe Medical GmbH | accessdata.fda.gov |
Compare with other makers
Updated May 13, 2011. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.