The following data is part of a premarket notification filed by Bm Korea Co., Ltd. with the FDA for Synster Pedicle Screw System Synster Plus Pedicle Screw System.
| Device ID | K120353 |
| 510k Number | K120353 |
| Device Name: | SYNSTER PEDICLE SCREW SYSTEM SYNSTER PLUS PEDICLE SCREW SYSTEM |
| Classification | Orthosis, Spondylolisthesis Spinal Fixation |
| Applicant | BM KOREA CO., LTD. 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Contact | Priscilla Chung |
| Correspondent | Priscilla Chung BM KOREA CO., LTD. 951 STARBUCK ST. UNIT J Fullerton, CA 92833 |
| Product Code | MNH |
| CFR Regulation Number | 888.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-02-06 |
| Decision Date | 2012-05-09 |
| Summary: | summary |