510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K043339Substantially Equivalent

Refix Pin (Plla), Models 2070L, 2770L, 3570L, 4570L; (Plga), Models 2070Lg, 2770Lg, 3570Lg, 4570Lg

Xtremi-T, LLC, Lawrenceville NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K043339 is the FDA 510(k) clearance record for REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG, a class II device, cleared for Xtremi-T, LLC on under FDA product code HTY (Pin, Fixation, Smooth). FDA records list 2 510(k) clearances for Xtremi-T, LLC, from to . As of , FDA records show no recalls naming K043339.

Clearance record

Decision date
Received
(136 days to decision)
Product code
HTY Pin, Fixation, Smooth
Regulation
21 CFR 888.3040
Device class
Class II
Review panel
Orthopedic
Applicant
Xtremi-T, LLC 3131 Princeton Pike, Bldg. 5, Lawrenceville NJ
510(k) summary
Summary PDF
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