Atlas FDA

Allograft Delivery Device (OFAC-C)

FDA 510(k) clearance K233368 · decided 2024-06-25

Clearance details

K-number
K233368
Device name
Allograft Delivery Device (OFAC-C)
Applicant
Bioventus, LLC
Decision
Substantially Equivalent
Date received
2023-10-02
Decision date
2024-06-25
Days to decision
267 days
Clearance type
Traditional
Product code
FMF
Device class
2
Regulation number
880.5860
Medical specialty
General Hospital
Advisory committee
General Hospital
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