510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K160830Substantially Equivalent

Integra External Fixation System

Ascension Orthopedics, Inc., Austin TX / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K160830 is the FDA 510(k) clearance record for Integra External Fixation System, a class II device, cleared for Ascension Orthopedics on under FDA product code KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component). FDA records list 29 510(k) clearances for Ascension Orthopedics, from to . As of , FDA records show 2 recalls naming K160830.

Clearance record

Decision date
Received
(103 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
Ascension Orthopedics 8700 Cameron Rd., Suite 100, Austin TX
510(k) summary
Summary PDF
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