510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K964458Substantially Equivalent

Ellis External Mini-Fixator System

Link America, Inc., Sarasota FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K964458 is the FDA 510(k) clearance record for ELLIS EXTERNAL MINI-FIXATOR SYSTEM, a class II device, cleared for Link America, Inc. on under FDA product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component). FDA records list 21 510(k) clearances for Link America, Inc., from to . As of , FDA records show no recalls naming K964458.

Clearance record

Decision date
Received
(32 days to decision)
Product code
KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Link America, Inc. 3700 S. Tamiami Trl., Sarasota FL
510(k) summary
Statement
Third party review
No

Clearances, product code KTT

Trailing 12 months
8 clearances under product code KTT in the twelve months to October 2026, November 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code KTT, trailing twelve months
MonthClearances
November 20252
December 20252
January 20261
February 20260
March 20261
April 20261
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260