The following data is part of a premarket notification filed by Surgitech, Inc. with the FDA for Spartan Orthopaedic Wrist Brace, Model Sct-1.
| Device ID | K031576 |
| 510k Number | K031576 |
| Device Name: | SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 |
| Classification | Orthosis, Limb Brace |
| Applicant | SURGITECH, INC. 2424 VISTA WAY, SUITE 300 Oceanside, CA 92054 |
| Contact | Christopher Crowell |
| Correspondent | Christopher Crowell SURGITECH, INC. 2424 VISTA WAY, SUITE 300 Oceanside, CA 92054 |
| Product Code | IQI |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-20 |
| Decision Date | 2003-07-31 |