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

Shelton, CT, US

Avitus Orthopaedics, Inc appears in FDA device records in Shelton, CT. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. 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
5
PMA records
0
Recall records
2
Registered establishments
1

510(k) clearance history

FDA records hold 5 510(k) clearances for Avitus Orthopaedics, Inc between 2015 and 2023. The busiest year on record is 2023, with 2. The most recent is 2023, with 2.

Clearances by year, as a table
510(k) clearance decisions for Avitus Orthopaedics, Inc, by decision year
YearClearances
20151
20171
20211
20232
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K231456Avitus® DragonWing Large Volume Autograft Delivery SystemFMFSubstantially Equivalent
K230492Avitus® Precision Autograft Delivery SystemFMFSubstantially Equivalent
K210631Avitus(r) Bone HarvesterKNWSubstantially Equivalent
K170539Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mmKNWSubstantially Equivalent
K152474Avitus Bone HarvesterKNWSubstantially Equivalent

Registered establishments

FDA registered establishments for Avitus Orthopaedics, Inc, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30115049933011504993Avitus Orthopaedics, Inc6 Armstrong Rd., Suite 107, Shelton, CT 06484 US2026

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-1047-2019Avitus Bone Harvester w/ Filter Insert - 5mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-210 The Avitus Bone Harvester is intended to harvest cancellous bone and bone marrowBreach in the sterile barrier pouch may compromise sterility of the device.Class IITerminated
Z-1046-2019Avitus Bone Harvester w/ Filter Insert - 8mm intended to harvest cancellous bone and bone marrow Catalog Number: BH-110 The Avitus Bone Harvester is intended to harvest cancellous bone and bone marrowBreach in the sterile barrier pouch may compromise sterility of the device.Class IITerminated

Verification record

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