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510(k) K802032

MINI MICK APPLICATOR by Mick Radio-Nuclear Instruments, Inc. — Product Code JWJ

K802032 is an FDA 510(k) premarket notification submitted by Mick Radio-Nuclear Instruments, Inc. for the device "MINI MICK APPLICATOR". The FDA issued a decision of Substantially Equivalent on October 23, 1980. The device falls under product code JWJ (Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained), a Class II device regulated under 21 CFR 888.3800. Mick Radio-Nuclear Instruments, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 23, 1980
Date Received
August 22, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained
Device Class
Class II
Regulation Number
888.3800
Review Panel
OR
Submission Type

Other clearances by Mick Radio-Nuclear Instruments, Inc.

  • K230155 — Mick Valencia Applicator Set (August 30, 2023)
  • K200221 — CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Appl (February 28, 2020)
  • K150979 — CT/MR Compatible M.A.C. Interstitial GYN Template (May 31, 2016)
  • K142597 — Vienna System (February 19, 2015)
  • K122840 — CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 (December 14, 2012)
  • K063382 — HDR CT COMPATIBLE SPLIT RING APPLICATOR (December 26, 2006)
  • K063381 — CT COMPATIBLE F/S/D APPLICATORS (December 22, 2006)
  • K052351 — HDR IORT SHIELDED APPLICATOR (October 17, 2005)
  • K051423 — MICK HDR INTERSTITIAL IMPLANT ACCESSORIES (July 1, 2005)
  • K040704 — MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLI (June 18, 2004)

Other clearances for product code JWJ

  • K243381 — Total Wrist Arthroplasty System (TWA) (November 1, 2024)
  • K233574 — Total Wrist Arthroplasty System (TWA) (July 3, 2024)
  • K233674 — Freedom Wrist Arthroplasty System (May 30, 2024)
  • K200718 — Arthrosurface WristMotion Total Wrist Arthroplasty System (October 15, 2020)
  • K191525 — KinematX Total Wrist Arthroplasty System (March 4, 2020)
  • K132250 — INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM (March 24, 2014)
  • K080426 — MAESTRO WRIST FRACTURE IMPLANT (July 29, 2008)
  • K042032 — MAESTRO TOTAL WRIST (October 7, 2004)
  • K031203 — BIAX A.F. WRIST/BIAX ADVANCED FIXATION WRIST (July 14, 2003)
  • K030037 — UNIVERSAL TOTAL WRIST SYSTEM (February 5, 2003)

FDA data resources