The following data is part of a premarket notification filed by Biomedical Ent., Inc. with the FDA for Osstaple.
| Device ID | K023203 |
| 510k Number | K023203 |
| Device Name: | OSSTAPLE |
| Classification | Staple, Fixation, Bone |
| Applicant | BIOMEDICAL ENT., INC. 14785 OMICRON DR., SUITE 205 San Antonio, TX 78245 |
| Contact | W. Casey Fox |
| Correspondent | W. Casey Fox 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-25 |
| Decision Date | 2002-10-17 |
| Summary: | summary |