510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K950864Substantially Equivalent

Gts Great Toe System - (Metatarsal Component with Porous Coating)

Acu Med, Inc., Beaverton OR / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950864 is the FDA 510(k) clearance record for GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING), cleared for Acu Med, Inc. on under FDA product code LZJ (Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained). FDA records list 48 510(k) clearances for Acu Med, Inc., from to . As of , FDA records show no recalls naming K950864.

Clearance record

Decision date
Received
(154 days to decision)
Product code
LZJ Prosthesis, Toe (Metatarsophalangeal), Joint, Metal/Polymer, Semi-Constrained
Device class
Unclassified
Review panel
Unknown
Applicant
Acu Med, Inc. 10950 SW 5th St., Beaverton OR
510(k) summary
Statement
Third party review
No

Clearances, product code LZJ

Trailing 12 months

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

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