The following data is part of a premarket notification filed by Biomedics with the FDA for The Titanium Fixation System.
| Device ID | K943071 |
| 510k Number | K943071 |
| Device Name: | THE TITANIUM FIXATION SYSTEM |
| Classification | Plate, Bone |
| Applicant | BIOMEDICS 6081 SAN RAFAEL DRIVE. Buena Park, CA 90620 |
| Contact | Carol E Jones |
| Correspondent | Carol E Jones BIOMEDICS 6081 SAN RAFAEL DRIVE. Buena Park, CA 90620 |
| Product Code | JEY |
| CFR Regulation Number | 872.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-28 |
| Decision Date | 1995-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M384P4ST1699US0 | K943071 | 000 |
| M384812009CP1 | K943071 | 000 |
| M3848120090 | K943071 | 000 |
| M384812008US0 | K943071 | 000 |
| M3848120080 | K943071 | 000 |
| M384812007US0 | K943071 | 000 |
| M384812007CP1 | K943071 | 000 |
| M3848120070 | K943071 | 000 |
| M384812002US0 | K943071 | 000 |
| M384812002CP1 | K943071 | 000 |
| M3848120020 | K943071 | 000 |
| M3848133670 | K943071 | 000 |
| M3848133640 | K943071 | 000 |
| M3848133420 | K943071 | 000 |
| M384812009US0 | K943071 | 000 |
| M3848120101 | K943071 | 000 |
| M384P4ST16990 | K943071 | 000 |
| M384P4LR08400 | K943071 | 000 |
| M384P4LR0424US0 | K943071 | 000 |
| M384P4LR04240 | K943071 | 000 |
| M384P4LL08400 | K943071 | 000 |
| M384P4LL0424US0 | K943071 | 000 |
| M384P4LL04240 | K943071 | 000 |
| M384P2CP08300 | K943071 | 000 |
| M384P2BW08240 | K943071 | 000 |
| M384P2BW04100 | K943071 | 000 |
| M384813060US0 | K943071 | 000 |
| M3848130600 | K943071 | 000 |
| M3848130590 | K943071 | 000 |
| M3848133400 | K943071 | 000 |