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510(k) K032331

DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY) by Pro-Med Instruments GmbH — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 20, 2003
Date Received
July 29, 2003
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 Pro-Med Instruments GmbH

  • K063494 — DORO RADIOLUCENT HEADREST SYSTEM ( ALSO MRI-COMPATIBLE) AND COMPONENTS (May 21, 2007)
  • K070997 — DORO NON-STICK BIPOLAR FORCEPS, MODEL 5001-XX TO 5012-XX, DORO BIPOLAR REUSABLE (May 16, 2007)
  • K001808 — DORO HEADREST SYSTEM (August 4, 2000)

Other clearances for product code HBL

  • K250423 — mb-FIX Cranial Stabilization Systems (November 6, 2025)
  • K241883 — DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); D (July 26, 2024)
  • 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)