The following data is part of a premarket notification filed by Beijing Libeier Bio-engineering Institute Co., Ltd with the FDA for Locking Plate System.
| Device ID | K132642 |
| 510k Number | K132642 |
| Device Name: | LOCKING PLATE SYSTEM |
| Classification | Plate, Fixation, Bone |
| Applicant | BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Contact | Diana Hong |
| Correspondent | Diana Hong BEIJING LIBEIER BIO-ENGINEERING INSTITUTE CO., LTD P.O. BOX 120-119 Shanghai, CN 200120 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-08-26 |
| Decision Date | 2013-10-03 |
| Summary: | summary |