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510(k) K932918

Device
TOTAL KNEE KIT
Applicant
BIODYNAMIC TECHNOLOGIES, INC.
510(k) number
K932918
Product code
HWE  
Decision
Substantially Equivalent (SESE)
Decision date
1994-09-01
Date received
1993-06-15
Regulation
878.4820
Classification name
Instrument, Surgical, Orthopedic, Ac-powered Motor And Accessory/attachment
Medical specialty
General & Plastic Surgery
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
ANDREW E TAYLOR
Address
727 Twenty-Third St. S. Arlington VA US 22202 22202

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code HWE  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K143191IntelliSense DrillMcginley Innovations2015-02-20
K102743ORTHO SOLUTIONS - STERILE, DRILLS, TAPS, GUIDE PINS & WIRESOrtho Solutions Limited2011-01-20
K063688SURGICAL IRRIGATION SYSTEM, IRRIGATION TUBEThe Anspach Effort, Inc.2007-01-16
K050766EXPLANT OSTEONECROSIS INTERVENTION IMPLANT REMOVAL SYSTEMZimmer Trabecular2005-05-26
K043310SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEMSynthes (Usa)2005-01-05
K022744REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSMedical Device Services2002-09-18
K012676REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPSAdven Medical2002-02-04
K012694REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURSAdven Medical2002-02-04
K990816AVCORE SYSTEMModular Cutting Systems, Inc.1999-09-24
K973736AESCULAP HILAN MOTOR SYSTEMAesculap, Inc.1997-12-29
K973560BONE GRAFT HARVESTERDs Mfg., Inc.1997-11-12
K972508SURGICAL BURS AND SURGICAL DRILL BITSSynvasive Technology, Inc.1997-08-26
K971342DISK WHISK CUTTING DEVICE (CONICAL, ELLIPTICAL AND BALL HEAD)Disk Whisk, Inc.1997-07-08
K971544SYNTHES (USA) COMPACT AIR DRIVE II (CAD II)Synthes (Usa)1997-05-28
K962087SERVOTRONIC EC100 SYSTEMMedicon, Inc.1997-04-23

Legacy Summary#

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FDA Review#

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