The following data is part of a premarket notification filed by Aesculap Implant Systems, Llc with the FDA for Hto Plating System.
| Device ID | K102505 |
| 510k Number | K102505 |
| Device Name: | HTO PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Contact | Kathy A Racosky |
| Correspondent | Kathy A Racosky AESCULAP IMPLANT SYSTEMS, LLC 3773 Corporate Parkway Center Valley, PA 18034 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-01 |
| Decision Date | 2010-11-24 |
| Summary: | summary |