Cartiva, Inc
United StatesFDA 510(k) applicant, unverified
- Devices
- 33
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA recalls
What Cartiva, Inc makes
Cartiva, Inc. manufactures synthetic cartilage implants and related instrumentation for spinal and joint procedures, including spinal column instrumentation sets and a hammer toe correction device. Their products are designed for surgical applications in orthopedic and spinal surgeries, such as spinal fusion and joint reconstruction.
The company’s portfolio includes devices regulated as Class II and Class III under FDA guidelines, with submissions recorded via 510(k) clearances and PMA applications. These products are listed in the FDA’s regulatory databases and are intended for use in the United States.
Catalogue
Search and filter all 33 devicesCompany details
- DUNS number
- 078582549
- [email protected]
- Phone
- 770-754-3800
FDA recalls
FDA recall records list 1 recall initiated by CARTIVA, INC, initiated on 2024-10-31. By recorded status: 1 ongoing. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 31 Oct 2024 Z-0598-2025 Class II Ongoing Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation.
Full distribution text
- 31 Oct 2024 Z-0598-2025 Class II Ongoing Patients implanted with synthetic cartilage implant, may experience a higher-than expected occurrence rate of the following hazards: revision, removal, implant subsidence, displacement, pain, nerve damage or fragmentation.
Frequently asked questions
How many devices does CARTIVA, INC have in the registry?
The registry currently lists 33 devices for CARTIVA, INC. Devices recorded under merged duplicate company entries are counted once.
Which registries list CARTIVA, INC's devices?
Among its 33 most recently registered devices, CARTIVA, INC has devices listed in FDA 510(k) (3 devices), FDA PMA (1 device) and FDA GUDID (29 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do CARTIVA, INC's devices fall under?
Among its 33 most recently registered devices, the classes recorded for CARTIVA, INC's devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.
Are there FDA recall records for CARTIVA, INC?
FDA recall records list 1 recall initiated by CARTIVA, INC, the most recent initiated on 2024-10-31. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from CARTIVA, INC in the registry?
The most recently registered devices listed for CARTIVA, INC include Cartiva SCI Metatarsal Drill Bit MTD-12, Cartiva SCI Introducer INT-06-G1, Cartiva ProxiFuse PRF-01 and Cartiva SCI Placer PLC-10-US.