FDA.reportPublic FDA data

510(k) K081025

Device
ISOELASTICU
Applicant
Remi Sciences, Inc.
510(k) number
K081025
Product code
KXE
Decision
Substantially Equivalent (SESE)
Decision date
2008-11-21
Date received
2008-04-10
Regulation
888.3810
Classification name
Prosthesis, Wrist, Hemi-, Ulnar
Medical specialty
Orthopedic
Review panel
Orthopedic
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SANJIV H NAIDU
Address
745 Bent Creek Dr. Lititz PA US 17543 17543

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code KXE#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
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K053119DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC2005-12-07
K052137ASCENSION MUHAscension Orthopedics, Inc.2005-11-03
K040497DISTAL RADIO-ULNAR JOINT IMPLANTAptis Medical, LLC2005-01-26
K042902HERBERT ULNAR HEAD PROSTHESIS SYSTEMStuckenbrock Medizintechnik GmbH2004-12-27
K033930KAPP CUSTOM ULNAR HEAD WRIST IMPLANTKapp Surgical Instrument, Inc.2004-07-28
K020274WMT MODULAR ULNAR HEAD IMPLANTWrightmedicaltechnologyinc2002-02-22
K010786ULNAR HEAD IMPLANTAvanta Orthopaedics, Inc.2001-04-11
K982268ULNAR HEAD IMPLANTAvanta Orthopaedics, Inc.1998-12-04
K812053SILASTIC HEMI WRIST IMPLANT H.P. (RAD.)Dow Corning Corp. Healthcare Industries Materials1981-08-18
K790125ULNAR HEAD PROTHESISCutter Laboratories, Inc.1979-02-08