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510(k) K091439

HEAD FIXATION ARC AND TABLE BASE by Surgivision, Inc. — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 25, 2009
Date Received
May 14, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Head, Neurosurgical (Skull Clamp)
Device Class
Class II
Regulation Number
882.4460
Review Panel
NE
Submission Type

Other clearances by Surgivision, Inc.

  • K102101 — SURGIVISION MR COMPATIBLE VENTRICULAR CANNULA (January 26, 2011)
  • K100836 — CLEARPOINT SYSTEM (June 16, 2010)
  • K091343 — MRI NEURO DRAPE (September 22, 2009)

Other clearances for product code HBL

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  • K240319 — DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101. (April 24, 2024)
  • K203505 — DORO QR3 Headrest System (Aluminum) (March 29, 2021)
  • K193438 — DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable S (June 2, 2020)
  • K191740 — DORO LUCENT® iXI and iMRI Headrest System (February 21, 2020)
  • K191701 — Arcus Head Fixation Frame (November 15, 2019)
  • K191979 — DORO QR3 XTom Headholder System (October 22, 2019)
  • K163322 — TZ SKULL PIN Adult (February 23, 2017)
  • K142238 — MAYFIELD Skull Clamp (November 24, 2014)