510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K931381Substantially Equivalent for Some Indications

Ame Universal Fixation System

American Medical Electronics, Inc., Richardson TX / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K931381 is the FDA 510(k) clearance record for AME UNIVERSAL FIXATION SYSTEM, a class II device, cleared for American Medical Electronics, Inc. on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 14 510(k) clearances for American Medical Electronics, Inc., from to . As of , FDA records show no recalls naming K931381.

Clearance record

Decision date
Received
(685 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
American Medical Electronics, Inc. 250 E. Arapaho Rd., Richardson TX
Third party review
No

Clearances, product code KWP

Trailing 12 months

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

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