FDA.reportPublic FDA data

510(k) K013527

Device
MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEM
Applicant
SYNTHES (USA)
510(k) number
K013527
Product code
HTO  
Decision
Substantially Equivalent (SESE)
Decision date
2001-12-21
Date received
2001-10-23
Regulation
888.4540
Classification name
Reamer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
BONNIE J SMITH
Address
1690 Russell Rd. Paoli PA US 19301 19301

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code HTO  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111437SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)Synthes (USA) Products, LLC2011-08-10
K042899SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONSSynthes (Usa)2005-03-16
K993335SYNTHES REAMER/IRRIGATOR/ASPIRATOR (RIA) SYSTEMSynthes (Usa)2000-06-12
K954915FLEXIBLE INTRAMEDULLARY REAMERZimmer, Inc.1995-12-28
K903248COMBINATION REAMEROnyx Medical Corp.1990-07-30
K885100MCCONNELL REAMER GUIDEMcconnell Orthopedic1989-01-13
K870845WARSAW ORTHOPEDIC POINTED REAMERWarsaw Orthopedic, Inc.1987-03-11
K862933ABC-1000 SMALL JOINT REAMERSInstrumentation Industries, Inc.1986-08-18
K832686MULTIPLE MANUAL SURGICAL INSTRUMENTSHirata Sangyo Co. USA, Inc.1983-10-14
K811081MEDULLARY CANAL SCRAPERSThe Anspach Effort, Inc.1981-04-29
K790996C.C.F. FEMORAL DEBRIDEMENT PROBEDepuy, Inc.1979-06-27
K790307FLEXIBLE REAMER, GUIDE WIRE SYSTEM3M Company1979-02-22
K770203HAND REAMERSDepuy, Inc.1977-02-08

Legacy Summary#

summary

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases