The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Cancellous Screw Long Thread Diameter 6.5mm.
| Device ID | K895219 |
| 510k Number | K895219 |
| Device Name: | CANCELLOUS SCREW LONG THREAD DIAMETER 6.5MM |
| Classification | Screw, Fixation, Bone |
| Applicant | ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Contact | Robert R Moore |
| Correspondent | Robert R Moore ORTHOPEDIC SYSTEMS, INC. 1897 NATIONAL AVE. Hayward, CA 94545 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-18 |
| Decision Date | 1989-09-12 |