The following data is part of a premarket notification filed by Changzhou Orthmed Medical Instrument Co., Ltd. with the FDA for Locking Compression Plate.
| Device ID | K101400 |
| 510k Number | K101400 |
| Device Name: | LOCKING COMPRESSION PLATE |
| Classification | Plate, Fixation, Bone |
| Applicant | CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. ZHONGSHAN NO. 2 ROAD (SOUTH) SUITE 5D, # 19, LANE 999 Shanghai, CN 200030 |
| Contact | Diana Hong |
| Correspondent | Diana Hong CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. ZHONGSHAN NO. 2 ROAD (SOUTH) SUITE 5D, # 19, LANE 999 Shanghai, CN 200030 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-18 |
| Decision Date | 2010-11-09 |