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510(k) K941558

MAYFIELD CHILD DISPOSABLE SKULL PIN by Ohio Medical Instrument Co., Inc. — Product Code HBL

K941558 is an FDA 510(k) premarket notification submitted by Ohio Medical Instrument Co., Inc. for the device "MAYFIELD CHILD DISPOSABLE SKULL PIN". The FDA issued a decision of Substantially Equivalent on December 6, 1995. The device falls under product code HBL (Holder, Head, Neurosurgical (Skull Clamp)), a Class II device regulated under 21 CFR 882.4460. Ohio Medical Instrument Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1995
Date Received
March 31, 1994
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 Ohio Medical Instrument Co., Inc.

  • K021604 — MAYFIELD RADIOLUCENT SKULL PINS, MODEL 4-0-A-2020 (July 29, 2002)
  • K013428 — MAYFIELD/ACCISS OPERATING ARM SYSTEM AND MAYFIELD/OPTICAL ACCISS SYSTEM (April 4, 2002)
  • K992843 — THE MAYFIELD / ACCISS SYSTEM WITH WINDOWS NT FOR CRANIAL SURGERY, THE MAYFIELD / (November 2, 1999)
  • K991267 — SPINE APPLICATIONS FOR THE MAYFIELD/ACCISS OPERATING ARM AND OPTICAL ACCISS SYST (July 12, 1999)
  • K983282 — OMI OCCIPITAL CERVICAL LOOP, MODEL A1089 (November 19, 1998)
  • K982244 — MAYFIELD ACCISS OPTICAL SYSTEM (September 23, 1998)
  • K960807 — TEW CRANIAL/SPINAL RETRACTOR MODEL A1090 (May 17, 1996)
  • K953124 — MAYFIELD RADIOLUCENT 2000 SKULL CLAMP (February 9, 1996)
  • K934289 — MAYFIELD RADIOLUCENT SKULL CLAMP (January 7, 1994)
  • K932807 — MAYFIELD* A-2000 SKULL CLAMP (September 28, 1993)

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)

FDA data resources