The following data is part of a premarket notification filed by Xiamen Double Engine Medical Material Co., Ltd with the FDA for Double Engine Bone Plate And Screw Systems.
| Device ID | K130108 |
| 510k Number | K130108 |
| Device Name: | DOUBLE ENGINE BONE PLATE AND SCREW SYSTEMS |
| Classification | Plate, Fixation, Bone |
| Applicant | XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD NO. 218, HOUXIANG ROAD HAICANG DISTRICT Xiamen, CN 361022 |
| Contact | Da Zeng |
| Correspondent | Da Zeng XIAMEN DOUBLE ENGINE MEDICAL MATERIAL CO., LTD NO. 218, HOUXIANG ROAD HAICANG DISTRICT Xiamen, CN 361022 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-01-16 |
| Decision Date | 2013-04-19 |
| Summary: | summary |