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510(k) K111437

Device
SYNTHES RIA SYSTEM (EXPANDED INDICATIONS)
Applicant
SYNTHES (USA) PRODUCTS LLC
510(k) number
K111437
Product code
HTO  
Decision
Substantially Equivalent (SESE)
Decision date
2011-08-10
Date received
2011-05-24
Regulation
888.4540
Classification name
Reamer
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
ANGELA F LASSANDRO
Address
1301 Goshen Pkwy. West Chester PA US 19380 19380

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
K042899SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONSSynthes (Usa)2005-03-16
K013527MODIFICATION TO SYNTHES (USA) REAMER IRRIGATOR ASPIRATOR (RIA) SYSTEMSynthes (Usa)2001-12-21
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#

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