TANGORS Multifunctional Posterior System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K120891 FDA 510(k)
- FDA Product Code
- NKB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 888.3070 FDA 510(k)
- Regulation Number
- 888.3070 FDA 510(k)
- Advisory Committee
- Orthopedic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The TANGORS Multifunctional Posterior System is a spinal fixation device comprising rods, polyaxial pedicle screws, and crosslinks with locking set screws. It is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion procedures.
The system is supplied in various sizes to accommodate patient anatomy and is intended for use by surgeons in clinical settings. The device is regulated under FDA 510(k) clearance and is manufactured by Ulrich GmbH & Co. KG.
Frequently asked questions
What is the TANGORS Multifunctional Posterior System used for?
The system is designed to provide immobilization and stabilization of spinal segments as an adjunct to fusion procedures.
What components are included in the system?
The system comprises rods, polyaxial pedicle screws, and crosslinks with locking set screws.
How is the device supplied?
The system is supplied in various sizes to accommodate patient anatomy and is intended for use by surgeons in clinical settings.
What is the regulatory status of this device?
The device is regulated under FDA 510(k) clearance and is manufactured by Ulrich GmbH & Co. KG.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF ulrich GmbH & Co. KG WS 35-MULI-eIFUś157363śR1/22-6 spine@ulrichmedical ..., TANGORS MULTIFUNCTIONAL POSTERIOR SYSTEM (K120891) — FDA 510(k ..., tangoRS™ multifunctional posterior system - BEUDAMED
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K120891 | Class II | Active |
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Manufacturer
- Manufacturer
- ulrich GmbH & Co. KG
Sources (1)
- FDA 510(k) K120891 24 fields · synced Sep 26, 2026