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510(k) K212156

ABCcolla Bone Matrix by Acro Biomedical Co., Ltd. — Product Code MQV

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 8, 2021
Date Received
July 12, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Filler, Bone Void, Calcium Compound
Device Class
Class II
Regulation Number
888.3045
Review Panel
OR
Submission Type

Other clearances by Acro Biomedical Co., Ltd.

  • K233378 — ABCcolla® Collagen ADM Scaffold (October 18, 2024)
  • K171629 — ABCcolla Bone Graft (February 1, 2018)
  • K162348 — ABCcolla Collagen Matrix (May 10, 2017)

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