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510(k) K063080

TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS by Advanced Neuromodulation Systems — Product Code GZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2006
Date Received
October 10, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Spinal-Cord, Implanted (Pain Relief)
Device Class
Class II
Regulation Number
882.5880
Review Panel
NE
Submission Type

Other clearances by Advanced Neuromodulation Systems

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  • K090907 — PENTA LEAD KITS, MODELS: 3227-3234 (June 2, 2009)
  • K081208 — CINCH ANCHOR, MODEL 1194 (July 18, 2008)
  • K072462 — WIDE SPACED QUATTRODE LEADS (October 11, 2007)
  • K070847 — TRIAL CABLE, 3009 (April 11, 2007)
  • K053250 — ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT (December 15, 2005)
  • K052374 — RAPID PROGEAMMER 3.0 (November 22, 2005)
  • K052418 — AXXESS BUTTERFLY ANCHOR (September 26, 2005)
  • K050922 — ANS SCS ACCESSORY KIT (May 18, 2005)
  • K050633 — TRIAL CABLE RETENTION CLIP (April 21, 2005)

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  • K202274 — Nalu Neurostimulation Kit (lnte:gmted 40 em: Single 8/Dual 8), Nalu Neurostimula (November 9, 2020)
  • K201618 — Nalu Neurostimulation SCS system (July 15, 2020)
  • K191466 — SandShark Injectable Anchor (SIA) System (November 7, 2019)
  • K190960 — Nalu Lead Blank (50cm) (July 11, 2019)
  • K182720 — Freedom Spinal Cord Stimulator (SCS) System (March 29, 2019)
  • K183047 — Nalu Neurostimulation System (March 22, 2019)
  • K180981 — Stimulator Kit, Trial Kit, Spare Lead Kit, Wearable Assembly Kit (September 19, 2018)