The following data is part of a premarket notification filed by Biomedical Ent., Inc. with the FDA for Speed Xl.
| Device ID | K133780 |
| 510k Number | K133780 |
| Device Name: | SPEED XL |
| Classification | Staple, Fixation, Bone |
| Applicant | BIOMEDICAL ENT., INC. 14785 OMICRON DR., SUITE 205 San Antonio, TX 78245 |
| Contact | Joe Soward |
| Correspondent | Joe Soward BIOMEDICAL ENT., 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 | 2013-12-12 |
| Decision Date | 2014-03-19 |
| Summary: | summary |