Data / Medical devices / United States / Avitus Orthopaedics, Inc
Avitus Orthopaedics, Inc: FDA-registered device maker in Shelton, CT, United States, 5 510(k) clearances
Avitus Orthopaedics, Inc is registered with the FDA (registration 3011504993) in Shelton, CT, United States. It lists 4 device types. The FDA files 5 510(k) clearances under its listings, the newest dated July 17, 2023. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3011504993
- Address
- 6 Armstrong Rd., Suite 107, Shelton, CT, United States, 06484
- Owner or operator
- Zimmer Inc. / Avitus Orthopaedics Inc. (10051767)
- Roles
- Specification developer
- First device listed
- May 2, 2016
- Registered through
- 2027
- Brand names listed
- Avitus, Avitus Bone Harvester 8mm, Avitus DragonWing Large Volume Autograft Delivery System, Avitus Pilot Hole Creator - 8mm x 20mm, Disposable, Avitus Pilot Hole Creator 11mm x 20mm, Avitus Precision Autograft Delivery System, Avitus® Bone Harvester Insert 8mm, Avitus® Bone Harvester with Filter Insert 5mm
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Instrument, Biopsy | KNW | 2 | Specification developer | accessdata.fda.gov |
| Orthopedic Manual Surgical Instrument | LXH | 1 | Specification developer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Specification developer | accessdata.fda.gov |
| Tray, Surgical, Instrument | FSM | 1 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 17, 2023 | K231456 | Avitus® DragonWing Large Volume Autograft Delivery System | FMF | Substantially Equivalent | Avitus Orthopaedics, Inc. | accessdata.fda.gov |
| June 26, 2023 | K230492 | Avitus® Precision Autograft Delivery System | FMF | Substantially Equivalent | Avitus Orthopaedics, Inc. | accessdata.fda.gov |
| March 31, 2021 | K210631 | Avitus(r) Bone Harvester | KNW | Substantially Equivalent | Avitus Orthopaedics, Inc. | accessdata.fda.gov |
| March 20, 2017 | K170539 | Avitus Bone Harvester with Filter Insert - 5mm, Avitus Bone Harvester - 5mm, Avitus Bone Harvester with Filter Insert - 8mm, Avitus Filter Insert - 8mm, Avitus Filter Insert - 5mm | KNW | Substantially Equivalent | Avitus Orthopaedics, Inc. | accessdata.fda.gov |
| October 23, 2015 | K152474 | Avitus Bone Harvester | KNW | Substantially Equivalent | Avitus Orthopaedics, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 18, 2019 | 82271 | Class II | Terminated | Avitus 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 marrow | Breach in the sterile barrier pouch may compromise sterility of the device. | accessdata.fda.gov |
Compare with other makers
- All makers of Tray, Surgical, Instrument
- All makers of Instrument, Biopsy
- All makers of Syringe, Piston
- All makers of Orthopedic Manual Surgical Instrument
Updated July 17, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.