510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K885100Substantially Equivalent

Mcconnell Reamer Guide

Mcconnell Orthopedic, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K885100 is the FDA 510(k) clearance record for MCCONNELL REAMER GUIDE, a class I device, cleared for Mcconnell Orthopedic on under FDA product code HTO (Reamer). FDA records list 16 510(k) clearances for Mcconnell Orthopedic, from to . As of , FDA records show no recalls naming K885100.

Clearance record

Decision date
Received
(32 days to decision)
Product code
HTO Reamer
Regulation
21 CFR 888.4540
Device class
Class I
Review panel
Orthopedic
Applicant
Mcconnell Orthopedic Treee Lincoln Centre, Dallas TX
Third party review
No

Clearances, product code HTO

Trailing 12 months

FDA records hold no clearances under product code HTO in the trailing twelve months.

FDA records show no clearances under product code HTO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HTO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260