The following data is part of a premarket notification filed by Sterilmed, Inc. with the FDA for Reprocessed External Fixation Accessories.
| Device ID | K081342 |
| 510k Number | K081342 |
| Device Name: | REPROCESSED EXTERNAL FIXATION ACCESSORIES |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | STERILMED, INC. 11400 73RD AVE. NORTH Maple Grove, MN 55369 |
| Contact | Joshua Clarin |
| Correspondent | Joshua Clarin 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 | 2008-05-13 |
| Decision Date | 2008-08-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10888551041362 | K081342 | 000 |
| 10888551041027 | K081342 | 000 |
| 10888551041010 | K081342 | 000 |
| 10888551041003 | K081342 | 000 |
| 10888551040990 | K081342 | 000 |
| 10888551040983 | K081342 | 000 |
| 10888551040976 | K081342 | 000 |
| 10888551040969 | K081342 | 000 |
| 10888551040952 | K081342 | 000 |
| 10888551040945 | K081342 | 000 |
| 10888551040938 | K081342 | 000 |
| 10888551040921 | K081342 | 000 |
| 10888551040914 | K081342 | 000 |
| 10888551040907 | K081342 | 000 |
| 10888551040891 | K081342 | 000 |
| 10888551040884 | K081342 | 000 |
| 10888551040877 | K081342 | 000 |
| 10888551041034 | K081342 | 000 |
| 10888551041041 | K081342 | 000 |
| 10888551041218 | K081342 | 000 |
| 10888551041201 | K081342 | 000 |
| 10888551041195 | K081342 | 000 |
| 10888551041188 | K081342 | 000 |
| 10888551041171 | K081342 | 000 |
| 10888551041164 | K081342 | 000 |
| 10888551041157 | K081342 | 000 |
| 10888551041140 | K081342 | 000 |
| 10888551041133 | K081342 | 000 |
| 10888551041126 | K081342 | 000 |
| 10888551041102 | K081342 | 000 |
| 10888551041096 | K081342 | 000 |
| 10888551041089 | K081342 | 000 |
| 10888551041072 | K081342 | 000 |
| 10888551041065 | K081342 | 000 |
| 10888551041058 | K081342 | 000 |
| 10888551040860 | K081342 | 000 |