The following data is part of a premarket notification filed by Meta Biomed Co., Ltd. with the FDA for Bonemedik, And Bonemedik-s.
| Device ID | K070897 |
| 510k Number | K070897 |
| Device Name: | BONEMEDIK, AND BONEMEDIK-S |
| Classification | Filler, Bone Void, Calcium Compound |
| Applicant | META BIOMED CO., LTD. 414-12 MO CHOONG DONG CHONG JU CITY, Choong Chong Buk Do, KR |
| Contact | Tae-hoon Kim |
| Correspondent | Tae-hoon Kim META BIOMED CO., LTD. 414-12 MO CHOONG DONG CHONG JU CITY, Choong Chong Buk Do, KR |
| Product Code | MQV |
| CFR Regulation Number | 888.3045 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-04-02 |
| Decision Date | 2007-09-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806387895404 | K070897 | 000 |
| 08806387895176 | K070897 | 000 |
| 08806387895169 | K070897 | 000 |
| 08806387895152 | K070897 | 000 |
| 08806387895145 | K070897 | 000 |
| 08806387895138 | K070897 | 000 |
| 08806387895121 | K070897 | 000 |
| 08806387895114 | K070897 | 000 |
| 08806387895107 | K070897 | 000 |
| 08806387895091 | K070897 | 000 |
| 08806387895084 | K070897 | 000 |
| 08806387895077 | K070897 | 000 |
| 08806387895060 | K070897 | 000 |
| 08806387895053 | K070897 | 000 |
| 08806387895046 | K070897 | 000 |
| 08806387895039 | K070897 | 000 |
| 08806387895022 | K070897 | 000 |
| 08806387895015 | K070897 | 000 |
| 08806387895183 | K070897 | 000 |
| 08806387895206 | K070897 | 000 |
| 08806387895213 | K070897 | 000 |
| 08806387895398 | K070897 | 000 |
| 08806387895381 | K070897 | 000 |
| 08806387895374 | K070897 | 000 |
| 08806387895367 | K070897 | 000 |
| 08806387895350 | K070897 | 000 |
| 08806387895343 | K070897 | 000 |
| 08806387895336 | K070897 | 000 |
| 08806387895329 | K070897 | 000 |
| 08806387895312 | K070897 | 000 |
| 08806387895305 | K070897 | 000 |
| 08806387895299 | K070897 | 000 |
| 08806387895282 | K070897 | 000 |
| 08806387895268 | K070897 | 000 |
| 08806387895251 | K070897 | 000 |
| 08806387895244 | K070897 | 000 |
| 08806387895237 | K070897 | 000 |
| 08806387895220 | K070897 | 000 |
| 08806387895008 | K070897 | 000 |