510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K874913Substantially Equivalent

Orthomet Pin System

Orthomet, Inc., Minneapolis MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874913 is the FDA 510(k) clearance record for ORTHOMET PIN SYSTEM, a class II device, cleared for Orthomet, Inc. on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 60 510(k) clearances for Orthomet, Inc., from to . As of , FDA records show no recalls naming K874913.

Clearance record

Decision date
Received
(35 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Orthomet, Inc. 6301 Cecilia Cir., Minneapolis MN
Third party review
No

Clearances, product code HTY

Trailing 12 months
2 clearances under product code HTY in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HTY, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20261
September 20260
October 20260