The following data is part of a premarket notification filed by Vanguard Medical Concepts, Inc. with the FDA for Vanguard Reprocessed External Fixation Devices.
| Device ID | K031687 |
| 510k Number | K031687 |
| Device Name: | VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Contact | Heather Crawford |
| Correspondent | Heather Crawford VANGUARD MEDICAL CONCEPTS, INC. 5307 GREAT OAK DR. Lakeland, FL 33815 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-02 |
| Decision Date | 2004-04-30 |
| Summary: | summary |