The following data is part of a premarket notification filed by Applied Osteo Systems, Inc. with the FDA for Texas Scottish Rite Easy/lock Fixator.
| Device ID | K931578 |
| 510k Number | K931578 |
| Device Name: | TEXAS SCOTTISH RITE EASY/LOCK FIXATOR |
| Classification | Component, Traction, Invasive |
| Applicant | APPLIED OSTEO SYSTEMS, INC. 1243 ALPINE RD. SUITE 221 Walnut Creek, CA 94596 -4370 |
| Contact | Michael Pentopoulos |
| Correspondent | Michael Pentopoulos APPLIED OSTEO SYSTEMS, INC. 1243 ALPINE RD. SUITE 221 Walnut Creek, CA 94596 -4370 |
| Product Code | JEC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-03-30 |
| Decision Date | 1994-02-22 |