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510(k) K083803

FIXIT HEADREST CLAMP SYSTEM by Medicon EG — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 2010
Date Received
December 22, 2008
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 Medicon EG

  • K161680 — MEDICON Spinal Spreading Systems (March 24, 2017)
  • K100916 — MEDICON MOGEN CLAMP (December 6, 2010)
  • K053624 — MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM (July 17, 2006)
  • K050478 — MEDICON IMF-ORION SCREWS (June 15, 2005)
  • K043297 — MEDICON 2.4 MANDIBULAR RECONSTRUCTION PLATING SYSTEM (February 23, 2005)
  • K042974 — MEDICON VIPAIR HIGH SPEED SYSTEM (January 13, 2005)
  • K041527 — AARHUS ANCHORAGE SYSTEM (August 19, 2004)
  • K010910 — MEDICON YASARGIL CLIP APPLYING FORCEPS (August 1, 2001)
  • K010908 — MEDICON TITANIUM YASARGIL ANEURYSM CLIPS (August 1, 2001)
  • K972857 — SERVOTRONIC EC100 SYSTEM (January 16, 1998)

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  • 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)