Home / 510(k) Clearances / K221821

510(k) K221821

ATEC IOM Accessory Instruments by Alphatec Spine, Inc. — Product Code PDQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 2022
Date Received
June 23, 2022
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Neurosurgical Nerve Locator
Device Class
Class II
Regulation Number
874.1820
Review Panel
NE
Submission Type

To locate or monitor function of spinal nerve roots or peripheral nerves during neurosurgery.

Other clearances by Alphatec Spine, Inc.

  • K252597 — Valence Robotic Navigation System; Valence Robotic Navigation Instruments (For U (February 19, 2026)
  • K252842 — SafeOp 3: Neural Informatix System (January 11, 2026)
  • K251575 — IdentiTi™ II ALIF Standalone Interbody System; Transcend™ ALIF Standalone Interb (September 3, 2025)
  • K251965 — Proximity Anterior Cervical Plate System; Segmental Plating System (SPS) (August 28, 2025)
  • K251080 — IdentiTi II Cervical Interbody System (July 3, 2025)
  • K243461 — Calibrate Interbody Systems (March 4, 2025)
  • K241375 — IdentiTi Porous Ti Interbody System; IdentiTi NanoTec Interbody System; IdentiTi (February 3, 2025)
  • K242364 — IdentiTi™ II Interbody System (October 4, 2024)
  • K242147 — Calibrate LTX Interbody System; Calibrate NanoTec LTX Interbody System (September 20, 2024)
  • K241519 — Invictus® Small Stature Spinal Fixation System (June 21, 2024)

Other clearances for product code PDQ

  • K243636 — Neuralytix iD3 System (NTX-9001) (June 26, 2025)
  • K223438 — TELIGEN System Peripheral Motor Nerve Stimulation Indications (February 10, 2023)
  • K220160 — PediGuard Threaded (March 31, 2022)
  • K203684 — Neurosign V4 Intraoperative Nerve Monitor (March 17, 2021)
  • K201454 — DSG Connect Technology (February 10, 2021)
  • K191723 — ATEC IOM Accessory Instruments (October 18, 2019)
  • K190163 — ALARA Neuro Access Kit (July 16, 2019)
  • K182617 — ATEC IOM Accessory Instruments (May 9, 2019)
  • K182662 — NAV PAK Needle, NIM NAV PAK Needle (April 10, 2019)
  • K181559 — Neurosign V4 Intraoperative Nerve Monitor (November 9, 2018)