510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K212570Substantially Equivalent

OsteoPlan System

Osteomed, Addison TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K212570 is the FDA 510(k) clearance record for OsteoPlan System, a class II device, cleared for Osteomed, LLC on under FDA product code DZJ (Driver, Wire, And Bone Drill, Manual). FDA records list 73 510(k) clearances for Osteomed, LLC, from to . As of , FDA records show no recalls naming K212570.

Clearance record

Decision date
Received
(179 days to decision)
Product code
DZJ Driver, Wire, And Bone Drill, Manual
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Osteomed, LLC 3885 Arapaho Rd., Addison TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DZJ

Trailing 12 months
1 clearance under product code DZJ in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DZJ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260