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510(k) K152920

Savannah-T® Pedicle Screw System by Amendia, Inc. — Product Code NKB

K152920 is an FDA 510(k) premarket notification submitted by Amendia, Inc. for the device "Savannah-T® Pedicle Screw System". The FDA issued a decision of Substantially Equivalent on July 8, 2016. The device falls under product code NKB (Thoracolumbosacral Pedicle Screw System), a Class II device regulated under 21 CFR 888.3070. Amendia, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2016
Date Received
October 2, 2015
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 Amendia, Inc.

  • K160924 — Amendia Interbody Fusion Devices (November 8, 2016)
  • K161842 — Overwatch Spine System (October 13, 2016)
  • K153152 — Syzygy Stabilization System (April 27, 2016)
  • K160291 — Optimus ALIF System (February 18, 2016)
  • K152972 — Amendia Stand-Alone Cervical System (January 14, 2016)
  • K151310 — Amendia Interbody Fusion Devices (January 6, 2016)
  • K152460 — Rectangular Corpectomy Cage (December 22, 2015)
  • K152455 — Amendia Cervical Plate System (October 15, 2015)
  • K151322 — Amendia Interbody Fusion Devices (September 10, 2015)
  • K150395 — Omega LIF System (August 10, 2015)

Other clearances for product code NKB

  • K253943 — Tiger 2 System (July 24, 2026)
  • K260362 — QUATTRO Spinal system (Open Configuration); QUATTRO-GADGET Spinal system (MIS Co (July 24, 2026)
  • 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)

FDA data resources