Valorem Surgical
Country not established
- Devices
- 1
- FDA recalls
- 144
At a glance
Market reach
- United States
- FDA recalls
What Valorem Surgical makes
Valorem Surgical manufactures the MAXIMIS Spinal Fixation System, a device designed for internal spinal stabilization and fusion procedures.
The MAXIMIS Spinal Fixation System is classified as a Class II medical device under FDA regulations and is listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Maximis Spinal Fixation System Ref K140359
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 144 recalls initiated by Valorem Surgical, initiated on 2017-06-21. By recorded status: 144 terminated. 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 144
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 21 Jun 2017 Z-2873-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2874-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2875-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2876-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2877-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2878-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2879-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2880-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2881-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2882-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
Show the 25 most recent of 144 recalls
2017
- 21 Jun 2017 Z-2883-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2884-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2885-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2886-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2887-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2888-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2889-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2890-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2891-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2892-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2893-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2894-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2895-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2896-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
- 21 Jun 2017 Z-2897-2017 Class II Terminated Devices are not consistent with Quality System Requirements.
Frequently asked questions
How many devices does Valorem Surgical have in the registry?
The registry currently lists 1 device for Valorem Surgical. Devices recorded under merged duplicate company entries are counted once.
Which registries list Valorem Surgical's devices?
Among its 1 most recently registered device, Valorem Surgical has devices listed in FDA 510(k) (1 device).
What risk classes do Valorem Surgical's devices fall under?
Among its 1 most recently registered device, the classes recorded for Valorem Surgical's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Valorem Surgical?
FDA recall records list 144 recalls initiated by Valorem Surgical, the most recent initiated on 21 Jun 2017. 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 Valorem Surgical in the registry?
The most recently registered devices listed for Valorem Surgical include MAXIMIS SPINAL FIXATION SYSTEM.