The following data is part of a premarket notification filed by Dj Orthopedics, Llc with the FDA for High Tibial Osteotomy Plating System.
| Device ID | K011354 |
| 510k Number | K011354 |
| Device Name: | HIGH TIBIAL OSTEOTOMY PLATING SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | DJ ORTHOPEDICS, LLC 990 PARK CENTER DRIVE, SUITE H Vista, CA 92083 |
| Contact | Jamal D Rushdy |
| Correspondent | Jamal D Rushdy DJ ORTHOPEDICS, LLC 990 PARK CENTER DRIVE, SUITE H Vista, CA 92083 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-03 |
| Decision Date | 2001-07-31 |