The following data is part of a premarket notification filed by Biomedical Enterprises, Inc. with the FDA for Elite Nitinol Fixation System.
| Device ID | K150125 |
| 510k Number | K150125 |
| Device Name: | Elite Nitinol Fixation System |
| Classification | Staple, 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 | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-01-20 |
| Decision Date | 2015-05-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810633022030 | K150125 | 000 |
| 00810633021972 | K150125 | 000 |
| 00810633021965 | K150125 | 000 |
| 00810633021958 | K150125 | 000 |
| 07612334226679 | K150125 | 000 |
| 07612334226662 | K150125 | 000 |
| 07612334226655 | K150125 | 000 |