The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed Pins.
| Device ID | K100707 |
| 510k Number | K100707 |
| Device Name: | REPROCESSED PINS |
| Classification | Pin, Fixation, Threaded, Metallic |
| Applicant | STERILMED, INC. 11400 73RD AVE. N. Maple Grove, MN 55369 |
| Contact | Garrett Ahlborg |
| Correspondent | Garrett Ahlborg STERILMED, INC. 11400 73RD AVE. N. Maple Grove, MN 55369 |
| Product Code | NDM |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-12 |
| Decision Date | 2010-06-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551027861 | K100707 | 000 |
| 10888551027854 | K100707 | 000 |
| 10888551027847 | K100707 | 000 |
| 10888551027830 | K100707 | 000 |
| 10888551027823 | K100707 | 000 |
| 10888551027816 | K100707 | 000 |
| 10888551027809 | K100707 | 000 |
| 10888551027793 | K100707 | 000 |