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510(k) K210963

ENNOVATE Spinal System by Aesculap Implant Systems, LLC — Product Code NKB

K210963 is an FDA 510(k) premarket notification submitted by Aesculap Implant Systems, LLC for the device "ENNOVATE Spinal System". The FDA issued a decision of Substantially Equivalent on July 19, 2021. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Aesculap Implant Systems, LLC has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2021
Date Received
March 31, 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 Aesculap Implant Systems, LLC

  • K213871 — Ennovate Cervical Spinal and Occiput System (July 1, 2022)
  • K180433 — ENNOVATE® (April 26, 2018)
  • K162134 — ENNOVATE Spinal System (December 14, 2016)
  • K153700 — Aesculap(R) Implant Systems (AIS) S4 Navigation Instruments (July 8, 2016)
  • K153629 — ArcadiusXP C Spinal System (May 25, 2016)
  • K153396 — Aesculap OrthoPilot Next Generation (May 16, 2016)
  • K151938 — S4 Cervical Spinal and Occiput Systems (October 21, 2015)
  • K151056 — Aesculap T-Space PEEK and XP Spinal System (August 13, 2015)
  • K150544 — Columbus Total Knee System, Columbus Revision Knee System, EnduRo Knee System (May 29, 2015)
  • K141694 — AESCULAP ORTHOPILOT NEXT GENERATION (February 24, 2015)

Other clearances for product code NKB

  • K261284 — Invictus® Small Stature Spinal Fixation System; Invictus® 2.0 Spinal Fixation Sy (July 14, 2026)
  • K253802 — KHEIRON® Spinal Fixation System, including patient specific K-ROD (July 1, 2026)
  • K253045 — “Socko” Vimax Spinal Fixation System (June 17, 2026)
  • K251251 — ChanPin Pedicle Screw Spinal System (June 9, 2026)
  • K260989 — Varion Thoracolumbar Fixation System (May 15, 2026)
  • K253739 — SCRIPT™ Rods, CREO™ Stabilization System, REVERE® Stabilization System, REVERE® (May 7, 2026)
  • K261130 — AccelFix Spinal Fixation System (May 5, 2026)
  • K253966 — PERLA® TL Posterior Thoraco-lumbar Fixation System (May 1, 2026)
  • K252542 — LEO Spinal System (April 29, 2026)
  • K253940 — M.U.S.T. Pedicle Screw System - Extension (April 28, 2026)

FDA data resources