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510(k) K052418

AXXESS BUTTERFLY ANCHOR by Advanced Neuromodulation Systems — Product Code GZB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 2005
Date Received
September 2, 2005
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)
  • K063080 — TRIPOLE 8C AND 16C AND EXCLAIM 8 LAMITRODE SERIES LEADS (December 12, 2006)
  • K053250 — ANS 90 CM AND 110 CM (3100 AND 3200 SERIES) LEAD KIT (December 15, 2005)
  • K052374 — RAPID PROGEAMMER 3.0 (November 22, 2005)
  • K050922 — ANS SCS ACCESSORY KIT (May 18, 2005)
  • K050633 — TRIAL CABLE RETENTION CLIP (April 21, 2005)

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  • K182720 — Freedom Spinal Cord Stimulator (SCS) System (March 29, 2019)
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