The following data is part of a premarket notification filed by Tri-med, Inc. with the FDA for Trimed Radial Bullet.
| Device ID | K030877 |
| 510k Number | K030877 |
| Device Name: | TRIMED RADIAL BULLET |
| Classification | Plate, Fixation, Bone |
| Applicant | TRI-MED, INC. 159 KU'UKAMA ST. Kailua,, HI 96734 |
| Contact | Robert J Medoff |
| Correspondent | Robert J Medoff TRI-MED, INC. 159 KU'UKAMA ST. Kailua,, HI 96734 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-03-20 |
| Decision Date | 2004-02-05 |
| Summary: | summary |