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510(k) K212066

Adena-Zina System by Shanghai Sanyou Medical Co, Ltd. — Product Code NKB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2021
Date Received
July 2, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Thoracolumbosacral Pedicle Screw System
Device Class
Class II
Regulation Number
888.3070
Review Panel
OR
Submission Type

Intended to provide immobilization and stabilization of spinal segments in thoracic, lumbar, and sacral spine as an adjunct to fusion.

Other clearances by Shanghai Sanyou Medical Co, Ltd.

  • K230872 — Halis™ Lumbar Cage System, Lydia™ Anterior Lumbar Fusion System, Dica™ Direction (December 12, 2023)
  • K230961 — Zeus Spinal System (October 10, 2023)
  • K231931 — Adena-Zina Spinal System (July 28, 2023)
  • K211689 — KEYSTONE PEEK Cage System (September 21, 2021)
  • K163366 — Shanghai Sanyou CARMEN Cervical Fusion System (October 5, 2017)
  • K163422 — Shanghai Sanyou PEEK Cage System (September 18, 2017)
  • K152781 — Adena-Zina System (February 12, 2016)
  • K131512 — KATIA SYSTEM (August 7, 2013)

Other clearances for product code NKB

  • K254274 — ARx® SAI Implant System (April 16, 2026)
  • K260786 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (April 3, 2026)
  • K254247 — OSTEOMNI SPINAL FIXATION SYSTEM (February 24, 2026)
  • K253169 — Duet™ Spinal Fixation System (February 23, 2026)
  • K253545 — Vulcan Spinal System (February 10, 2026)
  • K252461 — Swedge™ Pedicle Screw Fixation System Bezier Rod (January 13, 2026)
  • K253941 — CD Horizon™ ModuLeX™ Spinal System (LigaMAS Head Assembly) (January 7, 2026)
  • K253990 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (January 7, 2026)
  • K253093 — Vital™ Spinal Fixation System (December 17, 2025)
  • K253721 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (December 17, 2025)