The following data is part of a premarket notification filed by Applied Osteo Systems, Inc. with the FDA for True/flex Clavicle Rods.
| Device ID | K934148 |
| 510k Number | K934148 |
| Device Name: | TRUE/FLEX CLAVICLE RODS |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | APPLIED OSTEO SYSTEMS, INC. 1515 OAKLAND BLVD., SUITE 110 Walnut Creek, CA 94596 |
| Contact | Michael A Pentopoulos |
| Correspondent | Michael A Pentopoulos APPLIED OSTEO SYSTEMS, INC. 1515 OAKLAND BLVD., SUITE 110 Walnut Creek, CA 94596 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-25 |
| Decision Date | 1994-02-22 |