Cleared Traditional

HIP FIXATION SYSTEM

K950866 · Medtec, Inc. · Radiology
May 1995
Decision
92d
Days
Class 2
Risk

About This 510(k) Submission

K950866 is an FDA 510(k) clearance for the HIP FIXATION SYSTEM, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on May 30, 1995, 92 days after receiving the submission on February 27, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number K950866 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1995
Decision Date May 30, 1995
Days to Decision 92 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement

Device Classification

Product Code IYE — Accelerator, Linear, Medical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.5050

Similar Devices — IYE Accelerator, Linear, Medical

All 727
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · Varian Medical Systems, Inc. · Jan 2026
EMLA (Elekta Evo); EMLA (VersaHD); EMLA (Elekta Harmony Pro); EMLA (Elekta Infintiy); EMLA (Elekta Harmony); EMLA (Elekta Synergy)
K252188 · Elekta Solutions AB · Jan 2026
ExacTrac Dynamic (2.0.2); ExacTrac Dynamic Surface
K254010 · Brainlab SE · Jan 2026
ChartCheck (RADCH V1.6)
K252988 · Radformation, Inc. · Jan 2026
IDENTIFY (5.0)
K252919 · Varian Medical Systems, Inc. · Dec 2025
ZAP-X Radiosurgery System (ZAP-X)
K250392 · Zap Surgical Systems, Inc. · Nov 2025