510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K963394Substantially Equivalent

Osteomed Tram

Osteomed, Irving TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K963394 is the FDA 510(k) clearance record for OSTEOMED TRAM, a class II device, cleared for Osteomed Corp. on under FDA product code JEY (Plate, Bone). FDA records list 73 510(k) clearances for Osteomed Corp., from to . As of , FDA records show no recalls naming K963394.

Clearance record

Decision date
Received
(78 days to decision)
Product code
JEY Plate, Bone
Regulation
21 CFR 872.4760
Device class
Class II
Review panel
Dental
Applicant
Osteomed Corp. 3150 Premier Dr., Irving TX
510(k) summary
Statement
Third party review
No

Clearances, product code JEY

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