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Zimmer Sesamoid™ System (OS Unicondylar Knee Replacement) - HSA Registration DE0008766

Access comprehensive regulatory information for Zimmer Sesamoid™ System (OS Unicondylar Knee Replacement) in the Singapore medical device market through Pure Global AI's free database. This CLASS B medical device is registered under HSA registration number DE0008766 and owned by Zimmer CAS. The device was registered on March 07, 2012.

This page provides complete registration details including product owner information, registrant details, importer information, and regulatory compliance data from the official Singapore HSA medical device database. Pure Global AI offers free access to Singapore's complete medical device registry, helping global MedTech companies navigate HSA regulations efficiently.

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CLASS B
DE0008766
Zimmer Sesamoid™ System (OS Unicondylar Knee Replacement)
HSA Registration Number: DE0008766
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Product Description

Computer Assisted Surgery system intended to assist in positioning orthopedic Unicondylar Knee Replacement implant and instrument components intra-operatively by displaying their positions relative to the bone structures of interest that are modeled pre-operatively from radiology images, or relative to their alignment axes as based on anatomical landmarks that are identified intra-operatively by the user.

Device Classification
Device Class
CLASS B
Medical Speciality Area
Orthopaedics
HSA Product Code
HSAMDB00107
HS Code
90211000
Registration Information
Registration Number
DE0008766
Registration Date
March 07, 2012
Retention Due Date
March 06, 2026
Product Owner
Short Name
Zimmer CAS
Address
75 Queen Street, Suite 3300, Montreal, Quebec, CANADA
Registrant
Address
401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Importer
Address
401 COMMONWEALTH DRIVE, HAW PAR TECHNO CENTRE, #06-03, SINGAPORE 149598
Model Information
Model Name(s)
CAS FIX PIN FLTD 3.2D X 150MM CAS FIX PIN FLTD 3.2D X 80MM CAS FIX PIN FLTD 3.2D X 80MMx12 CAS FIX PIN FLTD 3.2DX150MM-12 CAS NAVITRACK KIT A-KNEE/SPINE CAS CALIBRATION STAR HOLDER CAS U-TKA VALIDATION TOOL CAS U-TKA DIST POST COND DIG CAS UNV OFFSET PADDLE 1MM CAS UNIV OFFSET PADDLE 1.27MM CAS UNV OFFSET PADDLE MAGNET CAS VALIDATION PADDLE CAS 2 PIN BONE REF FEMUR TS3 CAS OFS 2 PIN REF RT TIBIA SZ6 CAS OFS 2 PIN REF LT TIBIA SZ6 CAS WING SCREW M5X10 CAS UTKR LOWER INSERT CAS UTKR UPPER 1/2 INSERT CAS KNEE UNIV NAMEPLATE CAS SET SCREW M8 X 1.25MM CAS SCRDRVR 3.5MM W/CONCTR M12 CAS REGISTER POINTER CAS MAIN CASE CAS LID CAS NAVITRACKER PLIERS CAS COMP/CAMERA TRANSPT BOX CAS SESMD PLASTY TRANSPT BAG CAS SESMD PLTY TRANSPT BAG CVR CAS SESMD PLASTY CAMERA P7 CAS SESMD PLSTY SGL STANDN P7 CAS SESMD PLASTY COMPUTER Sesamoid Plasty CPU Kit AAEON CAS UNI KNEE INST SUB KT CAS SESMD PLSTY TRANSPT SET
Model Identifier(s)
20800000001 20800000002 20800000003 20800000004 20800000007 20800001001 20800001006 20800001017 20800001028 20800001029 20800001030 20800001031 20800001033 20800001035 20800001036 20800001037 20800001038 20800001039 20800001051 20800002021 20800002022 20800007001 20800007002 20800007003 20800007005 20800007030 20800007033 20800007034 20800007035 20800007036 20800007046 20800007064 KT800001004 KT800007009