The following data is part of a premarket notification filed by Diamond Orthopedic, Llc with the FDA for Diamond Orthopedic Bone Fixation Screws And Pins.
| Device ID | K180932 |
| 510k Number | K180932 |
| Device Name: | Diamond Orthopedic Bone Fixation Screws And Pins |
| Classification | Screw, Fixation, Bone |
| Applicant | Diamond Orthopedic, LLC 1104 Spruce St Belmont, NC 28012 |
| Contact | Roy Bivens |
| Correspondent | Lauren Smith JALEX Medical 30311 Clemens Road Suite 5D Westlake, OH 44145 |
| Product Code | HWC |
| Subsequent Product Code | HTY |
| Subsequent Product Code | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-10 |
| Decision Date | 2018-05-09 |
| Summary: | summary |