The following data is part of a premarket notification filed by Techmedica, Inc. with the FDA for Techmedia Bone Staple.
| Device ID | K813567 |
| 510k Number | K813567 |
| Device Name: | TECHMEDIA BONE STAPLE |
| Classification | Staple, Fixation, Bone |
| Applicant | TECHMEDICA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | JDR |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-12-22 |
| Decision Date | 1982-01-12 |