510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K923032Substantially Equivalent

Fixel External Fixation Device

Amp, Inc., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K923032 is the FDA 510(k) clearance record for FIXEL EXTERNAL FIXATION DEVICE, a class II device, cleared for Amp, Inc. on under FDA product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component). FDA records list one 510(k) clearance for Amp, Inc. As of , FDA records show no recalls naming K923032.

Clearance record

Decision date
Received
(468 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
Amp, Inc. 1054 31st St. NW, Washington DC
510(k) summary
Summary
Third party review
No

Clearances, product code KTT

Trailing 12 months
9 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 20261