The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Bonemedik-dm.
| Device ID | K080772 |
| 510k Number | K080772 |
| Device Name: | BONEMEDIK-DM |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | META BIOMED CO., LTD. 414-21 MO CHOONG DONG, CHONG JU CITY Republic Of Korea, KR |
| Contact | Tae-hoon Kim |
| Correspondent | Tae-hoon Kim META BIOMED CO., LTD. 414-21 MO CHOONG DONG, CHONG JU CITY Republic Of Korea, KR |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-03-19 |
| Decision Date | 2008-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806387896876 | K080772 | 000 |
| 08806387896777 | K080772 | 000 |
| 08806387896784 | K080772 | 000 |
| 08806387896791 | K080772 | 000 |
| 08806387896807 | K080772 | 000 |
| 08806387896814 | K080772 | 000 |
| 08806387896821 | K080772 | 000 |
| 08806387896838 | K080772 | 000 |
| 08806387896845 | K080772 | 000 |
| 08806387896852 | K080772 | 000 |
| 08806387896869 | K080772 | 000 |
| 08806387896760 | K080772 | 000 |