510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931678Substantially Equivalent

Orthomet Lhmc Femoral Stem

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

K931678 is the FDA 510(k) clearance record for ORTHOMET LHMC FEMORAL STEM, a class II device, cleared for Orthomet, Inc. on under FDA product code HMC (Monitor, Eye Movement, Diagnostic). FDA records list 60 510(k) clearances for Orthomet, Inc., from to . As of , FDA records show no recalls naming K931678.

Clearance record

Decision date
Received
(556 days to decision)
Product code
HMC Monitor, Eye Movement, Diagnostic
Regulation
21 CFR 886.1510
Device class
Class II
Review panel
Ophthalmic
Applicant
Orthomet, Inc. 6301 Cecilia Cir., Minneapolis MN
510(k) summary
Summary
Third party review
No

Clearances, product code HMC

Trailing 12 months

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

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