FDA 510(k) Application Details - K220337

Device Classification Name Filler, Bone Void, Calcium Compound

  More FDA Info for this Device
510(K) Number K220337
Device Name Filler, Bone Void, Calcium Compound
Applicant Corliber (Shenzhen) Medical Device Co., Ltd.
#103, BLK 6, 14 Zhongxing Rd, Kengzi Sub-district,
Pingshan District
Shenzhen City CN
Other 510(k) Applications for this Company
Contact Sun Yang
Other 510(k) Applications for this Contact
Regulation Number 888.3045

  More FDA Info for this Regulation Number
Classification Product Code MQV
Other 510(k) Applications for this Device

  More FDA Info for this Product Code
Date Received 02/07/2022
Decision Date 02/03/2023
Decision SESE - SUBST EQUIV
Classification Advisory Committee OR - Orthopedic
Review Advisory Committee OR - Orthopedic
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact