The following data is part of a premarket notification filed by L&k Biomed Co., Ltd. with the FDA for Pathloc-c Posterior Cervical Fixation System.
| Device ID | K153439 |
| 510k Number | K153439 |
| Device Name: | PathLoc-C Posterior Cervical Fixation System |
| Classification | Posterior Cervical Screw System |
| 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 | NKG |
| CFR Regulation Number | 888.3075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-11-27 |
| Decision Date | 2016-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806344307803 | K153439 | 000 |
| 08806344307476 | K153439 | 000 |
| 08806344312685 | K153439 | 000 |
| 08806344310131 | K153439 | 000 |
| 08806344309036 | K153439 | 000 |
| 08806344306929 | K153439 | 000 |
| 08806344306844 | K153439 | 000 |
| 08806344306592 | K153439 | 000 |
| 08806344306172 | K153439 | 000 |