510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K203282Substantially Equivalent

TECHFIT Patient-Specific Maxillofacial System

Industrias Medicas Sampedro S.A.S, La Estrella, CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K203282 is the FDA 510(k) clearance record for TECHFIT Patient-Specific Maxillofacial System, a class II device, cleared for Industrias Medicas Sampedro S.A.S on under FDA product code JEY (Plate, Bone). FDA records list 2 510(k) clearances for Industrias Medicas Sampedro S.A.S, from to . As of , FDA records show no recalls naming K203282.

Clearance record

Decision date
Received
(194 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Industrias Medicas Sampedro S.A.S Carrera 47 N 100 Sur 40 Centro Industrial Portal Del Sur, La Estrella, CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JEY

Trailing 12 months
5 clearances under product code JEY in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code JEY, trailing twelve months
MonthClearances
November 20251
December 20251
January 20260
February 20260
March 20260
April 20261
May 20260
June 20260
July 20261
August 20261
September 20260
October 20260