The following data is part of a premarket notification filed by Hospital Equipment Manufacturing Company with the FDA for Hemc Brand Locking Bone Plates And Screws Osteosynthesis Plating System.
| Device ID | K222282 |
| 510k Number | K222282 |
| Device Name: | HEMC BRAND Locking Bone Plates And Screws Osteosynthesis Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Hospital Equipment Manufacturing Company A19/A20, Sector 7 Noida, IN 201301 |
| Contact | Himanshu Sachdeva |
| Correspondent | Himanshu Sachdeva Hospital Equipment Manufacturing Company A19/A20, Sector 7 Noida, IN 201301 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-07-29 |
| Decision Date | 2022-10-27 |