The following data is part of a premarket notification filed by Biomedical Enterprises, Inc. with the FDA for Nitinol Compression Plating System.
| Device ID | K143023 |
| 510k Number | K143023 |
| Device Name: | Nitinol Compression Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | BioMedical Enterprises, Inc. 14785 Omicron Dr., Suite 205 San Antonio, TX 78245 |
| Contact | Joe Soward |
| Correspondent | Joe Soward BioMedical Enterprises, Inc. 14785 Omicron Dr., Suite 205 San Antonio, TX 78245 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-21 |
| Decision Date | 2015-01-16 |
| Summary: | summary |