Cleared Traditional

STRYKER KNIFELIGHT

K100884 · Howmedica Osteonics Corp. · General & Plastic Surgery
Jun 2010
Decision
87d
Days
Class 2
Risk

About This 510(k) Submission

K100884 is an FDA 510(k) clearance for the STRYKER KNIFELIGHT, a Lamp, Surgical (Class II — Special Controls, product code FTD), submitted by Howmedica Osteonics Corp. (Malwah, US). The FDA issued a Cleared decision on June 25, 2010, 87 days after receiving the submission on March 30, 2010. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K100884 FDA.gov
FDA Decision Cleared SESE
Date Received March 30, 2010
Decision Date June 25, 2010
Days to Decision 87 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTD — Lamp, Surgical
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

Similar Devices — FTD Lamp, Surgical

All 28
SCINTILLANT DUAL BENT TIP SURGICAL LIGHT, SCINTILLANT DUAL STRAIGHT TIP SURGICAL LIGHT
K133425 · Engineered Medical Solutions Co., LLC · Dec 2013
VOLISTA 400; VOLISTA 600
K130513 · Maquet S.A.S. · May 2013
POLARIS 100/200
K123776 · Drager Medical GmbH · Mar 2013
ATRICURE DISSECTOR
K111020 · AtriCure, Inc. · Jun 2011
HM-LAMP II
K100234 · Hillusa, Inc. · Jul 2010
SCINTILLANT SURGICAL LIGHT, MODEL 2644-01-0001
K071180 · Engineered Medical Solutions Co., LLC · Jun 2007

More from Howmedica Osteonics Corp.

View all
Exeter V40 Femoral Stem, Exeter X3 RimFit Cup
K193429 · JDI · Aug 2020
Triathlon Posterior Stabilized Femoral Component - beaded with Peri-Apatite, Triathlon Cruciate Retaining Femoral Component - beaded with Peri-Apatite
K200782 · MBH · May 2020
REUNION RSA SHOULDER SYSTEM
K130895 · PHX · Dec 2013
ABG III MONOLITHIC HIP STEM
K123604 · MAY · Aug 2013
DISTAL FEMORAL GROWING PROSTHESIS, TIBIAL ROTATING COMPONENTS, BEARING, AXIS, CIRCLIP, WEDGE
K122015 · KRO · Feb 2013