510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K861576Substantially Equivalent

Shortening Osteotomy Guide

Osteotomy Guide Co., Mesa AZ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K861576 is the FDA 510(k) clearance record for SHORTENING OSTEOTOMY GUIDE, a class I device, cleared for Osteotomy Guide Co. on under FDA product code HTH (Protractor). FDA records list 3 510(k) clearances for Osteotomy Guide Co., from to . As of , FDA records show no recalls naming K861576.

Clearance record

Decision date
Received
(14 days to decision)
Product code
HTH Protractor
Regulation
21 CFR 888.4600
Device class
Class I
Review panel
Orthopedic
Applicant
Osteotomy Guide Co. 1450 S. Dobson Rd. Suite 201, Mesa AZ
Third party review
No

Clearances, product code HTH

Trailing 12 months

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

FDA records show no clearances under product code HTH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HTH, 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