The following data is part of a premarket notification filed by Howmedica Corp. with the FDA for I.c.s. Mini & Small Fragment Set.
| Device ID | K800806 |
| 510k Number | K800806 |
| Device Name: | I.C.S. MINI & SMALL FRAGMENT SET |
| Classification | Plate, Fixation, Bone |
| Applicant | HOWMEDICA CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-10 |
| Decision Date | 1980-04-21 |