Vertebral Technologies, Inc.
United StatesFDA applicant, unverified
- Devices
- 7
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Vertebral Technologies, Inc. makes
Vertebral Technologies, Inc. manufactures intervertebral body fusion devices designed for spinal stabilization. These include variations such as the INTERFUSE Model 9076, INTERFUSE T, INTERFUSE DA, and INTERFUSE L, which are intended for surgical fusion of vertebrae in the spine. The devices are engineered to support bone growth across spinal segments, aiding in the treatment of degenerative disc disease or spinal instability.
The company’s intervertebral fusion devices fall under Class II classification in the US regulatory framework, requiring 510(k) clearance through the FDA. These products are listed in the FDA’s 510(k) database as authorised medical devices. The manufacturer is based in the United States.
Catalogue
- Regimes: 510(k) Registry: 510(k)
Interfuse T Invertebral Body Fusion Device Ref K110226
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Interfuse Intervertebral Body Fusion Device Ref K080673
Regimes: 510(k) Registry: 510(k)Interfuse T Invertebral Body Fusion Device Ref K102277
Regimes: 510(k) Registry: 510(k)Interfuse Da Invertebral Body Fusion Device Ref K110045
Regimes: 510(k) Registry: 510(k)Interfuse L Intervertebral Body Fusion Device Ref K131540
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Vertebral Technologies, Inc., initiated on 2017-01-13. By recorded status: 1 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 1
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 0
- 2025 0
- 2026 0
2017
- 13 Jan 2017 Z-1151-2017 Class II Terminated Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant. The InterFuse T Tail may not fit into the Thru Hole in the instrument.
Full distribution text
- 13 Jan 2017 Z-1151-2017 Class II Terminated Fit issues have been identified with the Tail Traction Tool (PN 9116) when used with the Interfuse T tailed implant. The InterFuse T Tail may not fit into the Thru Hole in the instrument.
Frequently asked questions
How many devices does Vertebral Technologies, Inc. have in the registry?
The registry currently lists 7 devices for Vertebral Technologies, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vertebral Technologies, Inc.'s devices?
Among its 7 most recently registered devices, Vertebral Technologies, Inc. has devices listed in FDA 510(k) (7 devices).
What risk classes do Vertebral Technologies, Inc.'s devices fall under?
Among its 7 most recently registered devices, the classes recorded for Vertebral Technologies, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Vertebral Technologies, Inc.?
FDA recall records list 1 recall initiated by Vertebral Technologies, Inc., the most recent initiated on 13 Jan 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 Vertebral Technologies, Inc. in the registry?
The most recently registered devices listed for Vertebral Technologies, Inc. include INTERFUSE INVERTEBRAL BODY FUSION DEVICE MODEL 9076, INTERFUSE T INVERTEBRAL BODY FUSION DEVICE, MODIFICATION TO: INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE, MODEL 9076 and INTERFUSE INTERVERTEBRAL BODY FUSION DEVICE.