Cleared Traditional

K874298: MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME

K874298 · Engineered Orthopedic Technologies, Inc. · Neurology
Feb 1988
Decision
107d
Days
Class 2
Risk

K874298 is an FDA 510(k) clearance for the MALCOLM-RAND MICRONEUROSURGICAL CRANIO-XRAY FRAME, a Holder, Head, Neurosurgical (skull Clamp) (Class II — Special Controls, product code HBL), submitted by Engineered Orthopedic Technologies, Inc. (San Clemente, US). The FDA issued a Cleared decision on February 4, 1988, 107 days after receiving the submission on October 20, 1987. This device falls under the Neurology review panel. Regulated under 21 CFR 882.4460.

Submission Details

510(k) Number K874298 FDA.gov
FDA Decision Cleared SESE
Date Received October 20, 1987
Decision Date February 04, 1988
Days to Decision 107 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary —

Device Classification

Product Code HBL — Holder, Head, Neurosurgical (skull Clamp)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 882.4460

Similar Devices — HBL Holder, Head, Neurosurgical (skull Clamp)

All 49
mb-FIX Cranial Stabilization Systems
K250423 · Medical Bees GmbH · Nov 2025
DORO Sterile Disposable Skull Pins Stainless Steel, Adult (36 pcs) (3006-00); DORO Sterile Disposable Skull Pins Stainless Steel, Pediatric (36 pcs) (3006-10); DORO Sterile Disposable Skull Pin Titanium, Adult (36 pcs) (3006-20); DORO Sterile Disposable Skull Pin Titanium, Pediatric (36 pcs) (3006-30); DORO Sterile Disposable Skull Pin Stainless Steel, Adult (36 pcs) (3006-50)
K241883 · Pro-Med Instruments GmbH · Jul 2024
DORO LUCENT Skull Clamp (1101.001); DORO LUCENT Skull Clamp Pediatric Set (1101.040)
K240319 · Pro-Med Instruments GmbH · Apr 2024
DORO QR3 Headrest System (Aluminum)
K203505 · Pro-Med Instruments GmbH · Mar 2021
DORO Sterile Disposable Skull Pins (Stainless Steel) , DORO Sterile Disposable Skull Pins (Titanium)
K193438 · Pro-Med Instruments GmbH · Jun 2020
DORO LUCENT? iXI and iMRI Headrest System
K191740 · Pro-Med Instruments GmbH · Feb 2020