The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Pathloc-si Joint Fusion System.
| Device ID | K153656 |
| 510k Number | K153656 |
| Device Name: | PathLoc-SI Joint Fusion System |
| Classification | Sacroiliac Joint Fixation |
| Applicant | L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu, Yongin-si, KR 446-916 |
| Contact | Yerim An |
| Correspondent | Yerim An L&K BIOMED Co., Ltd. #201, 202 16-25, Dongbaekjungang-ro 16 Beon-gil Giheung-gu, Yongin-si, KR 446-916 |
| Product Code | OUR |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-11-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806344337435 | K153656 | 000 |
| 08806344337381 | K153656 | 000 |
| 08806344337398 | K153656 | 000 |
| 08806344337404 | K153656 | 000 |
| 08806344337411 | K153656 | 000 |
| 08806344337428 | K153656 | 000 |
| 08806344337442 | K153656 | 000 |
| 08806344337459 | K153656 | 000 |
| 08806344337473 | K153656 | 000 |
| 08806344337374 | K153656 | 000 |
| 08806344337367 | K153656 | 000 |
| 08806344337275 | K153656 | 000 |
| 08806344337282 | K153656 | 000 |
| 08806344337299 | K153656 | 000 |
| 08806344337312 | K153656 | 000 |
| 08806344337329 | K153656 | 000 |
| 08806344337336 | K153656 | 000 |
| 08806344337343 | K153656 | 000 |
| 08806344337350 | K153656 | 000 |
| 08806344337480 | K153656 | 000 |
| 08806344337497 | K153656 | 000 |
| 08806344337206 | K153656 | 000 |
| 08806344337213 | K153656 | 000 |
| 08806344337220 | K153656 | 000 |
| 08806344337237 | K153656 | 000 |
| 08806344337244 | K153656 | 000 |
| 08806344337251 | K153656 | 000 |
| 08806344337466 | K153656 | 000 |
| 08806344337305 | K153656 | 000 |
| 08806344337190 | K153656 | 000 |
| 08806344337183 | K153656 | 000 |
| 08806344337503 | K153656 | 000 |
| 08806344342569 | K153656 | 000 |
| 08806344342576 | K153656 | 000 |
| 08806344337138 | K153656 | 000 |
| 08806344337145 | K153656 | 000 |
| 08806344337152 | K153656 | 000 |
| 08806344337169 | K153656 | 000 |
| 08806344337176 | K153656 | 000 |
| 08806344337268 | K153656 | 000 |