The following data is part of a premarket notification filed by Orthopedic Systems, Inc. with the FDA for Fixator Pin (external).
| Device ID | K881511 |
| 510k Number | K881511 |
| Device Name: | FIXATOR PIN (EXTERNAL) |
| Classification | Pin, Fixation, Threaded |
| 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 | JDW |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-11 |
| Decision Date | 1988-06-30 |