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510(k) K132496

Device
ARTHROSURFACE TOEMOTION
Applicant
ARTHROSURFACE, INC.
510(k) number
K132496
Product code
LZJ  
Decision
Substantially Equivalent (SESE)
Decision date
2014-02-26
Date received
2013-08-09
Regulation
510(k) Premarket Notification
Classification name
Prosthesis, Toe (metatarsophalangeal), Joint, Metal/polymer, Semi-constrained
Medical specialty
510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices
Review panel
Orthopedic
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
DAWN J WILSON
Address
28 Forge Pkwy. Franklin MA US 02038 02038

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code LZJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K102549THE ASCENSION MOVEMENT GREAT TOE SYSTEM TOTAL ARTHROPLASTYAscension Orthopedics, Inc.2010-12-21
K072251MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEMMerete Medical GmbH2008-05-08
K950864GTS GREAT TOE SYSTEM - (METATARSAL COMPONENT WITH POROUS COATING)Acu Med, Inc.1995-07-31
K941650TOTAL TOE SYSTEM IIBiomet, Inc.1994-12-19
K924724KINETIK GREAT TOE SYSTEMKinetikos Medical, Inc.1994-01-05
K922211OSTEOMED GREAT TOE SYSTEMOsteomed Corp.1993-11-09
K920446TOTAL TOE SYSTEMBiomet, Inc.1993-03-22
K920667GREAT TOE IMPLANTAcu Med, Inc.1992-06-19
K911552ANATOMIC TOE SYSTEMOrthopaedic Biosystems1991-06-28
K884561KOENIG TOTAL TOE IMPLANTDow Corning Wright1989-01-24

Legacy Summary#

summary

FDA Review#

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