The following data is part of a premarket notification filed by Dj Orthopedics, Llc with the FDA for Dj Orthopedics Interference Screw.
| Device ID | K010595 |
| 510k Number | K010595 |
| Device Name: | DJ ORTHOPEDICS INTERFERENCE SCREW |
| Classification | Screw, 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 | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-02-28 |
| Decision Date | 2001-05-08 |