OsteoMed PINNACLE Driver— 510(k) K162544

Name: FDA 510(k) clearance K162544
Creator: U.S. Food and Drug Administration
Published: 2017-04-04

Substantially Equivalent

Osteomed

FDA 510(k) clearance K162544 for OsteoMed PINNACLE Driver, Substantially Equivalent on 2017-04-04. Applicant: Osteomed. Device class: 2.

Clearance details

Applicant: Osteomed
Product code: Code KMW
Device class: Class 2
Regulation: 21 CFR 872.4120
Advisory panel: Dental
Date received: 2016-09-12
Decision date: 2017-04-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Addison, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMW

view all

K211584 — Oral Surgery Contra2021-08-19
K171155 — Surgical Angle Handpiece, Surgical Straight Handpiece2017-11-21
K080939 — SURGICAL HANDPIECES, MIKRO SAW HANDPIECES2008-07-29
K994298 — FRIOS MICROSAW2000-02-18
K971692 — OSTEOPOWER SYSTEM AND ACCESSORIES1997-06-27

More clearances from Osteomed

view all

K203479 — ExtremiLOCK Lateral Ankle Fusion Plates2021-02-24
K162542 — OsteoMed PINNACLE Driver2017-05-19
K161041 — OsteoMed ExtremiLOCK Wrist Plating System2016-05-19
K152145 — OsteoMed ExtremiLOCK Wrist Plating System2015-12-21
K151195 — OsteoMed IMF Screw2015-09-21

Adverse events under product code KMW

product code KMW

Injury: 175
Total: 175

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.