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510(k) K211613

Stern Fix Sternal Stabilization System by Neos Surgery S.L — Product Code JDQ

K211613 is an FDA 510(k) premarket notification submitted by Neos Surgery S.L for the device "Stern Fix Sternal Stabilization System". The FDA issued a decision of Substantially Equivalent on January 19, 2022. The device falls under product code JDQ (Cerclage, Fixation), a Class II device regulated under 21 CFR 888.3010. Neos Surgery S.L has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 19, 2022
Date Received
May 26, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cerclage, Fixation
Device Class
Class II
Regulation Number
888.3010
Review Panel
OR
Submission Type

Other clearances by Neos Surgery S.L

  • K240137 — Cranial LOOP, Cranial LOOP L and Cranial LOOP XL Cranial Bone Fixation System (February 16, 2024)
  • K221795 — STERN FIX Sternal Stabilization System (October 19, 2022)
  • K160739 — Cranial COVER (June 12, 2016)
  • K132044 — CRANIAL LOOP, CRANIAL LOOP L AND CRANIAL LOOP XL AND CRANIAL BONE FIXATION SYSTE (September 30, 2013)
  • K101235 — CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM (October 25, 2010)

Other clearances for product code JDQ

  • K261271 — Cable-Ready® Cable Grip System (July 16, 2026)
  • K243905 — Stitch Cerclage – Suture Tapes (August 14, 2025)
  • K243344 — Arthrex FiberTape and TigerTape Cerclage Sutures; Arthrex Radiopaque FiberTape C (February 20, 2025)
  • K232733 — Mbrace Cable (May 3, 2024)
  • K233949 — ACCORD Cable System (March 13, 2024)
  • K232986 — VariTrax Sternal CircumFixation System (January 30, 2024)
  • K230976 — Arthrex Radiopaque FiberTape Cerclage sutures (August 24, 2023)
  • K231333 — STRETTO™ Cable System (August 4, 2023)
  • K220765 — HS Fiber Cerclage (July 26, 2023)
  • K221795 — STERN FIX Sternal Stabilization System (October 19, 2022)

FDA data resources