510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850803Substantially Equivalent

Nail Splint

Inro Medical Designs, Inc., Desoto TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850803 is the FDA 510(k) clearance record for NAIL SPLINT, cleared for Inro Medical Designs, Inc. on under FDA product code MQZ (Prosthesis, Nail). FDA records list one 510(k) clearance for Inro Medical Designs, Inc. As of , FDA records show no recalls naming K850803.

Clearance record

Decision date
Received
(231 days to decision)
Product code
MQZ Prosthesis, Nail
Device class
Unclassified
Review panel
Unknown
Applicant
Inro Medical Designs, Inc. 2727 Bolton Boone Dr., #105, Desoto TX
Third party review
No

Clearances, product code MQZ

Trailing 12 months

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

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