The following data is part of a premarket notification filed by Suzhou Kangli Orthopaedics Instrument Co., Ltd with the FDA for Kangli Locking Plate System.
| Device ID | K133840 |
| 510k Number | K133840 |
| Device Name: | Kangli Locking Plate System |
| Classification | Plate, Fixation, Bone |
| Applicant | SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD 503 ROOM, 8 BUILDING, 600 LIU ZHOU ROAD Shanghai, CN 200233 |
| Contact | Alice Gong |
| Correspondent | Alice Gong SUZHOU KANGLI ORTHOPAEDICS INSTRUMENT CO., LTD 503 ROOM, 8 BUILDING, 600 LIU ZHOU ROAD Shanghai, CN 200233 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-12-18 |
| Decision Date | 2014-07-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06937762178033 | K133840 | 000 |
| 06937762166559 | K133840 | 000 |
| 06937762166535 | K133840 | 000 |
| 06937762166511 | K133840 | 000 |
| 06937762166504 | K133840 | 000 |
| 06937762166498 | K133840 | 000 |
| 06937762166481 | K133840 | 000 |
| 06937762166474 | K133840 | 000 |