510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K014302Substantially Equivalent

Universal Multiaxis (Unimax) Pedicle Screw System

Pisharodi Surgicals, Inc., Brownsville TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K014302 is the FDA 510(k) clearance record for UNIVERSAL MULTIAXIS (UNIMAX) PEDICLE SCREW SYSTEM, a class II device, cleared for Pisharodi Surgicals, Inc. on under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation). FDA records list 4 510(k) clearances for Pisharodi Surgicals, Inc., from to . As of , FDA records show no recalls naming K014302.

Clearance record

Decision date
Received
(88 days to decision)
Product code
MNH Orthosis, Spondylolisthesis Spinal Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Pisharodi Surgicals, Inc. 942 Wildrose Ln., Brownsville TX
510(k) summary
Summary
Third party review
No

Clearances, product code MNH

Trailing 12 months

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

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