The following data is part of a premarket notification filed by Bm Korea Co., Ltd. with the FDA for Synster (cervical,alif, Plif, Ptlif And Tlif) Cage Hera Cervical Cage Rhea Plif Cage Talon Tifa Cage.
| Device ID | K122518 |
| 510k Number | K122518 |
| Device Name: | SYNSTER (CERVICAL,ALIF, PLIF, PTLIF AND TLIF) CAGE HERA CERVICAL CAGE RHEA PLIF CAGE TALON TIFA CAGE |
| Classification | Intervertebral Fusion Device With Bone Graft, Cervical |
| 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 | ODP |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-08-17 |
| Decision Date | 2013-02-15 |
| Summary: | summary |