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510(k) K002276

PSI SKULL CLAMP by V. Mueller Neuro/Spine — Product Code HBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 29, 2000
Date Received
July 26, 2000
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 V. Mueller Neuro/Spine

  • K993019 — PACIFIC SURGICAL PATTIES (March 30, 2000)
  • K991959 — PSI TITANIUM ANEURYSM CLIP (January 6, 2000)
  • K991002 — PSI TITANIUM MICRO-LIGATION HEMOSTATIC CLIP (June 11, 1999)
  • K972750 — TAKA ANEURYSM CLIP (July 9, 1998)
  • K964402 — VERSATRAC (TM) LUMBAR RETRACTOR SYSTEM (January 23, 1997)
  • K942601 — PSI FLEXIBLE ARM (December 27, 1994)
  • K943635 — ULTRA-LINE RONGEUR (December 7, 1994)

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)