510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K183094Substantially Equivalent

CyclaPlex Correction System

Cycla Orthopedics, Ltd., Bat Shlomo, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183094 is the FDA 510(k) clearance record for CyclaPlex Correction System, a class II device, cleared for Cycla Orthopedics, Ltd. on under FDA product code HTN (Washer, Bolt Nut). FDA records list one 510(k) clearance for Cycla Orthopedics, Ltd. As of , FDA records show no recalls naming K183094.

Clearance record

Decision date
Received
(170 days to decision)
Product code
HTN Washer, Bolt Nut
Regulation
21 CFR 888.3030
Device class
Class II
Review panel
Orthopedic
Applicant
Cycla Orthopedics, Ltd. 14 Hame Yasdim St., Bat Shlomo, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HTN

Trailing 12 months
3 clearances under product code HTN 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 HTN, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260