The following data is part of a premarket notification filed by Osteomed Corp. with the FDA for Orthopedic Smooth Pin Fixation.
| Device ID | K932348 |
| 510k Number | K932348 |
| Device Name: | ORTHOPEDIC SMOOTH PIN FIXATION |
| Classification | Pin, Fixation, Smooth |
| Applicant | OSTEOMED CORP. 2753 FREEMAN ST. Fort Wayne, IN 46802 |
| Contact | Billy Darmawan |
| Correspondent | Billy Darmawan OSTEOMED CORP. 2753 FREEMAN ST. Fort Wayne, IN 46802 |
| Product Code | HTY |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-14 |
| Decision Date | 1994-03-01 |