510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K162544Substantially Equivalent

OsteoMed PINNACLE Driver

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

K162544 is the FDA 510(k) clearance record for OsteoMed PINNACLE Driver, a class II device, cleared for Osteomed on under FDA product code KMW (Handpiece, Rotary Bone Cutting). FDA records list 73 510(k) clearances for Osteomed, from to . As of , FDA records show no recalls naming K162544.

Clearance record

Decision date
Received
(204 days to decision)
Product code
KMW Handpiece, Rotary Bone Cutting
Regulation
21 CFR 872.4120
Device class
Class II
Review panel
Dental
Applicant
Osteomed 3885 Arapaho Rd., Addison TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KMW

Trailing 12 months

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

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