The following data is part of a premarket notification filed by Applied Osteo Systems, Inc. with the FDA for True/flex Intramedullary Rod End-cap.
| Device ID | K944501 |
| 510k Number | K944501 |
| Device Name: | TRUE/FLEX INTRAMEDULLARY ROD END-CAP |
| Classification | Rod, Fixation, Intramedullary And Accessories |
| Applicant | APPLIED OSTEO SYSTEMS, INC. 1243 ALPINE RD. SUITE 221 Walnut Creek, CA 94596 -4370 |
| Contact | Scott Huntley |
| Correspondent | Scott Huntley APPLIED OSTEO SYSTEMS, INC. 1243 ALPINE RD. SUITE 221 Walnut Creek, CA 94596 -4370 |
| Product Code | HSB |
| CFR Regulation Number | 888.3020 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-14 |
| Decision Date | 1994-11-28 |