Data / Medical devices / United States / Diamond Orthopedic
Diamond Orthopedic: FDA-registered device maker in Gastonia, NC, United States, 5 510(k) clearances
Diamond Orthopedic is registered with the FDA (registration 3013540005) in Gastonia, NC, United States. It lists 18 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 9, 2018. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3013540005
- Address
- 1669 Federal Ave, Gastonia, NC, United States, 28052
- Owner or operator
- Diamond Orthopedic (10054574)
- Roles
- Contract manufacturer, Manufacturer, Repackager or relabeler
- First device listed
- April 4, 2017
- Registered through
- 2026
- Brand names listed
- Diamond Orthopedic Bone Screw Starter, Diamond Orthopedic Bone Tap, Diamond Orthopedic Cancellous Screws, Diamond Orthopedic Cortical Screws, Diamond Orthopedic Countersink, Diamond Orthopedic Depth Guage, Diamond Orthopedic Drill Bit, Diamond Orthopedic Drill Brace and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bit, Drill | HTW | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Brace, Drill | HXY | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Countersink | HWW | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cutter, Wire | HXZ | 1 | Repackager or relabeler | accessdata.fda.gov |
| Driver, Prosthesis | HWR | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Forceps | HTD | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Gauge, Depth | HTJ | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Guide, Surgical, Instrument | FZX | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pin, Fixation, Smooth | HTY | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Pin, Fixation, Threaded | JDW | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Plate, Fixation, Bone | HRS | 2 | Repackager or relabeler | accessdata.fda.gov |
| Screw, Fixation, Bone | HWC | 2 | Contract manufacturer, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Screwdriver | HXX | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Starter, Bone Screw | HWD | 1 | Repackager or relabeler | accessdata.fda.gov |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tap, Bone | HWX | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Manufacturer, 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 9, 2018 | K180932 | Diamond Orthopedic Bone Fixation Screws and Pins | HWC | Substantially Equivalent | Diamond Orthopedic, LLC | accessdata.fda.gov |
| January 13, 2012 | K112727 | MEDICAL FACETS CORICAL SCREWS, MEDICAL FACETS CANCELLOUS SCREWS, MEDICAL FACETS HEADLESS COMPRESSION SCREWS, MEDICAL | HWC | Substantially Equivalent | Medical Facets | accessdata.fda.gov |
| May 13, 2011 | K102845 | MAHE FIXATION PLATE AND SCREW SYSTEM | HRS | Substantially Equivalent | Mahe Medical GmbH | accessdata.fda.gov |
| September 10, 2010 | K100736 | KIRSCHNER AND GUIDE WIRES | HTY | Substantially Equivalent | Smt Schilling Metalltechnik GmbH | accessdata.fda.gov |
| February 5, 2010 | K091493 | ORTHO SELECT BONE PLATES AND SCREW SYSTEM | HRS | Substantially Equivalent | Ortho Select Implant Technology Gesellschaft | accessdata.fda.gov |
Compare with other makers
- All makers of Driver, Prosthesis
- All makers of Screw, Fixation, Bone
- All makers of Plate, Fixation, Bone
- All makers of Pin, Fixation, Threaded
- All makers of Pin, Fixation, Smooth
- All makers of Guide, Surgical, Instrument
Updated May 9, 2018. 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.