510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131851Substantially Equivalent

Osteomed Neuro Rongeur

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

K131851 is the FDA 510(k) clearance record for OSTEOMED NEURO RONGEUR, a class II device, cleared for Osteomed on under FDA product code HAE (Rongeur, Manual). FDA records list 73 510(k) clearances for Osteomed, from to . As of , FDA records show no recalls naming K131851.

Clearance record

Decision date
Received
(168 days to decision)
Product code
HAE Rongeur, Manual
Regulation
21 CFR 882.4840
Device class
Class II
Review panel
Neurology
Applicant
Osteomed 3885 Arapaho Rd., Addison TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code HAE

Trailing 12 months
1 clearance under product code HAE in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code HAE, 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 20261
October 20260