Atlas FDA

MCS Bone Graft

FDA 510(k) clearance K162860 · decided 2017-02-13

Clearance details

K-number
K162860
Device name
MCS Bone Graft
Applicant
Bioventus, LLC
Decision
Substantially Equivalent
Date received
2016-10-12
Decision date
2017-02-13
Days to decision
124 days
Clearance type
Traditional
Product code
MQV
Device class
2
Regulation number
888.3045
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Durham, NC, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
DUROLANE (P170007/S015)Bioventus, LLC2025-12-23
EXOGEN® Ultrasound Bone Healing System (P900009/S049)Bioventus, LLC2023-12-21
DUROLANE (P170007/S014)Bioventus, LLC2022-10-14
Durolane (P170007/S013)Bioventus, LLC2022-03-03
DUROLANE (P170007/S012)Bioventus, LLC2022-03-02
DUROLANE (P170007/S011)Bioventus, LLC2022-01-25
Exogen (P900009/S048)Bioventus, LLC2022-01-07
DUROLANE (P170007/S010)Bioventus, LLC2021-12-22