510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Bioventus LLC

Durham, NC, US

BIOVENTUS LLC appears in FDA device records in Durham, NC. FDA records list 6 510(k) clearances between and , 61 PMA records and 2 registered establishments. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
6
PMA records
61
Recall records
2
Registered establishments
2

510(k) clearance history

FDA records hold 6 510(k) clearances for Bioventus LLC between 2017 and 2025. The busiest year on record is 2025, with 2. The most recent is 2025, with 2.

Clearances by year, as a table
510(k) clearance decisions for Bioventus LLC, by decision year
YearClearances
20171
20201
20231
20241
20252
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K243782StimTrial Neuromodulation SystemGZFSubstantially Equivalent
K243678TalisMann Neuromodulation SystemGZFSubstantially Equivalent
K233368Allograft Delivery Device (OFAC-C)FMFSubstantially Equivalent
K233490SIGNAFUSE Bioactive Strip (SBS); SIGNAFUSE PuttyMQVSubstantially Equivalent
K193513SIGNAFUSE Bioactive Bone GraftMQVSubstantially Equivalent
K162860MCS Bone GraftMQVSubstantially Equivalent

Registered establishments

FDA registered establishments for Bioventus LLC, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30095955773009595577BIOVENTUS LLC4721 Emperor Blvd Ste 100, Durham, NC 27703 US2026
30276697353027669735Bioventus LLC7101 Goodlett Farms Pkwy, Cordova, TN 38016 US2026and 1 more, listed in full below

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-0810-2021EXOGEN Ultrasound Coupling GelProduct may contain white particulates that are microbial in nature.Class IITerminated
Z-1148-2019BIOVENTUS Bioactive Bone Graft Putty 15g Rx only/sterile. Filler device intended for use in bony voids or gaps that are not intrinsic to the stability of the bony structure. Sold under the brand names of: SIGNAFUSE, OSTEOFUSE and MEDLINE UNITE.The firm became aware of the potential for the products' sterile pouch to be punctured during transit. The packaging failure may introduce a non-sterile device that may lead to patient infection.Class IITerminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain