The following data is part of a premarket notification filed by Aesculap Implant Systems, Inc. with the FDA for Aesculap Implant Systems High Tibial Osteotomy Plating System.
| Device ID | K080992 |
| 510k Number | K080992 |
| Device Name: | AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. Center Valley, PA 18034 |
| Contact | Lisa Boyle |
| Correspondent | Lisa Boyle AESCULAP IMPLANT SYSTEMS, INC. 3773 CORPORATE PKWY. Center Valley, PA 18034 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-04-07 |
| Decision Date | 2008-09-04 |
| Summary: | summary |