510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K000019Substantially Equivalent

Single Size Tendon Spacer

Medist International, Lakeland TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K000019 is the FDA 510(k) clearance record for SINGLE SIZE TENDON SPACER, a class II device, cleared for Medist International on under FDA product code HXA (Prosthesis, Tendon, Passive). FDA records list one 510(k) clearance for Medist International. As of , FDA records show no recalls naming K000019.

Clearance record

Decision date
Received
(85 days to decision)
Product code
HXA Prosthesis, Tendon, Passive
Regulation
21 CFR 888.3025
Device class
Class II
Review panel
Orthopedic
Applicant
Medist International 9160 Hwy. 64 Suite 12, Lakeland TN
510(k) summary
Summary
Third party review
No

Clearances, product code HXA

Trailing 12 months

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

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