The following data is part of a premarket notification filed by Biomedical Enterprises, Inc. with the FDA for Speed, Speed Shift, Speed Titan, Speed Arc.
| Device ID | K142292 |
| 510k Number | K142292 |
| Device Name: | Speed, Speed Shift, Speed Titan, Speed Arc |
| 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 | 2014-08-18 |
| Decision Date | 2014-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810633022023 | K142292 | 000 |
| 00810633022016 | K142292 | 000 |
| 00810633022009 | K142292 | 000 |
| 00810633021996 | K142292 | 000 |