510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K040346Substantially Equivalent

Modification to Oria Top Clip System

Ortho Tec, LLC, California CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K040346 is the FDA 510(k) clearance record for MODIFICATION TO ORIA TOP CLIP SYSTEM, a class II device, cleared for Ortho Tec, LLC on under FDA product code MNI (Orthosis, Spinal Pedicle Fixation). FDA records list 22 510(k) clearances for Ortho Tec, LLC, from to . As of , FDA records show no recalls naming K040346.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MNI Orthosis, Spinal Pedicle Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Ortho Tec, LLC 9595 Wilshire Blvd., Suite 502, California CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNI

Trailing 12 months

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

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