The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed External Fixation Device.
| Device ID | K083636 |
| 510k Number | K083636 |
| Device Name: | REPROCESSED EXTERNAL FIXATION DEVICE |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Garrett Ahlborg |
| Correspondent | Garrett Ahlborg STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-09 |
| Decision Date | 2009-03-02 |
| Summary: | summary |