The following data is part of a premarket notification filed by Bk Meditech Co., Ltd. with the FDA for Dyna-extor Ii.
| Device ID | K110426 |
| 510k Number | K110426 |
| Device Name: | DYNA-EXTOR II |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | BK MEDITECH CO., LTD. PO BOX 560 Stillwater, MN 55082 |
| Contact | Elaine Duncan |
| Correspondent | Elaine Duncan BK MEDITECH CO., LTD. PO BOX 560 Stillwater, MN 55082 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-02-14 |
| Decision Date | 2011-11-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809155852531 | K110426 | 000 |
| 08809155851381 | K110426 | 000 |
| 08809155851374 | K110426 | 000 |
| 08809155851367 | K110426 | 000 |
| 08809155851350 | K110426 | 000 |
| 08809155851343 | K110426 | 000 |
| 08809155851336 | K110426 | 000 |
| 08809155851329 | K110426 | 000 |
| 08809155851312 | K110426 | 000 |
| 08809155851305 | K110426 | 000 |
| 08809155851299 | K110426 | 000 |
| 08809155851282 | K110426 | 000 |
| 08809155851275 | K110426 | 000 |
| 08809155851541 | K110426 | 000 |
| 08809155851558 | K110426 | 000 |
| 08809155851572 | K110426 | 000 |
| 08809155852524 | K110426 | 000 |
| 08809155852517 | K110426 | 000 |
| 08809155852500 | K110426 | 000 |
| 08809155852050 | K110426 | 000 |
| 08809155852043 | K110426 | 000 |
| 08809155852036 | K110426 | 000 |
| 08809155851640 | K110426 | 000 |
| 08809155851633 | K110426 | 000 |
| 08809155851626 | K110426 | 000 |
| 08809155851619 | K110426 | 000 |
| 08809155851602 | K110426 | 000 |
| 08809155851589 | K110426 | 000 |
| 08809155851251 | K110426 | 000 |