The following data is part of a premarket notification filed by Biomedical Enterprises, Inc with the FDA for Osstaple, Ossplate, Ossforce.
| Device ID | K061385 |
| 510k Number | K061385 |
| Device Name: | OSSTAPLE, OSSPLATE, OSSFORCE |
| Classification | Appliance, Fixation, Spinal Intervertebral Body |
| Applicant | BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 San Antonio, TX 78245 |
| Contact | W. Casey Fox |
| Correspondent | W. Casey Fox BIOMEDICAL ENTERPRISES, INC 14785 OMICRON DR STE 205 San Antonio, TX 78245 |
| Product Code | KWQ |
| CFR Regulation Number | 888.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-05-18 |
| Decision Date | 2007-05-30 |
| Summary: | summary |