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Adena-Zina System

by Shanghai Sanyou Medical Co., Ltd.

510(k) K212066

Active European Union and United States

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K212066↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK212066 Date16 Aug 2021ClearedStatusActive
European UnionCE/MDD EUDAMED Number— Date—StatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

510(k) Number
FDA product code
NKB
FDA applicant
Shanghai Sanyou Medical Co, Ltd.
Device class
Class II
Regulation
21 CFR Part 888.3070
Advisory committee
Orthopedic
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Adena-Zina System is a thoracolumbosacral pedicle screw system, designed for spinal fixation and stabilization in orthopedic procedures. It consists of components intended for internal fixation of the spine, aiding in the correction and support of vertebral alignment during surgical interventions.

This system is supplied as a sterile, single-use device and is regulated under 21 CFR 888.3070, classified as a Class II medical device. It is intended for use in orthopedic settings, adhering to FDA 510(k) clearance (K212066) and the European Medical Device Directive (MDD). Components are provided in a sterile packaging for surgical use, with no indication of MRI compatibility or reusable applications.

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Questions

AI-generated answers, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of spinal procedures is the Adena-Zina System designed to support?

    The Adena-Zina System is specifically designed for thoracolumbosacral spinal fixation and stabilization during orthopedic surgeries. It aids in correcting and supporting vertebral alignment, making it suitable for procedures requiring internal spinal support in these regions.

  • Is the Adena-Zina System intended for reuse in multiple surgeries, or is it meant for single-use only?

    The Adena-Zina System is explicitly supplied as a sterile, single-use device. This means each component is intended for one surgical procedure only, ensuring patient safety and compliance with sterile medical device standards.

  • How is the Adena-Zina System packaged for surgical use, and what does this imply about its handling?

    The system comes in sterile packaging, which means it is pre-sterilized and ready for immediate surgical use without additional sterilization. This ensures contamination-free handling and adherence to aseptic techniques during orthopedic procedures.

  • What regulatory pathways has the Adena-Zina System followed, and how does this affect its availability?

    The Adena-Zina System has undergone FDA 510(k) clearance (K212066) under the Traditional pathway, classified as substantially equivalent to a predicate device, and complies with the European Medical Device Directive (MDD). This means it is legally marketed in the U.S. and EU markets, though buyers should verify local compliance requirements for their specific region.