FDA 510(k), K212156, ABCcolla Bone Matrix

510(K) Number: K212156
Device Name: ABCcolla Bone Matrix
Manufacturer: ACRO Biomedical Co., Ltd.
Device Classification Name: Filler, Bone Void, Calcium Compound
Regulation Number: 888.3045
Classification Product Code: MQV
Date Received: 07/12/2021
Decision Date: 10/08/2021
Regulation Medical Specialty: Orthopedic

184 pages (1,074 of 1,258 pages are fully redacted)