The following data is part of a premarket notification filed by Kronner Medical with the FDA for Kronner Sacral Pin Guide.
| Device ID | K895172 |
| 510k Number | K895172 |
| Device Name: | KRONNER SACRAL PIN GUIDE |
| Classification | Orthopedic Manual Surgical Instrument |
| Applicant | KRONNER MEDICAL 544 WEST UMPQUA SUITE 104 Roseburg, OR 97470 |
| Product Code | LXH |
| CFR Regulation Number | 888.4540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-10 |
| Decision Date | 1989-09-12 |