深圳立心科学GAIABONE™可塑形吸收性骨修复材料获美国FDA 510(K)上市，注册号为K220337。公司网站介绍该材料成分为聚乳酸和纳米羟基磷灰石共混物，抗溃散，骨诱导和成骨活性出色，仅需 3-6 个月即可完成骨再生。
| Device Classification Name | filler, bone void, calcium compound |
|---|---|
| 510(k) Number | K220337 |
| Device Name | GaiaBone Bioabsorbable Bone Graft |
| Applicant | Corliber (Shenzhen) Medical Device Co., Ltd.#103, BLK 6, 14 Zhongxing Rd, Kengzi Sub-District,Pingshan DistrictShenzhen City, CN |
| Applicant Contact | Sun Yang |
| Correspondent | Cosmos Biomed Consulting CO., LtdRoom 1201, No.1, 188 Alley, Shuangliu Road,Changning District,Shanghai City, CN |
| Correspondent Contact | Li-Ting Lu |
| Regulation Number | 888.3045 |
| Classification Product Code | MQV |
| Date Received | 02/07/2022 |
| Decision Date | 02/03/2023 |
| Decision | Substantially Equivalent (SESE) |
| Regulation Medical Specialty | Orthopedic |
| 510k Review Panel | Orthopedic |
| Type | Traditional |
| Reviewed by Third Party | No |
| Combination Product | No |