Pure Global

Wright Medical Mica Screw System - HSA Registration DE0503764

Access comprehensive regulatory information for Wright Medical Mica Screw System in the Singapore medical device market through Pure Global AI's free database. This CLASS C medical device is registered under HSA registration number DE0503764 and owned by Wright Medical Technology Inc.. The device was registered on October 23, 2019.

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.

Free Database
Powered by Pure Global AI
HSA Official Data
CLASS C
DE0503764
Wright Medical Mica Screw System
HSA Registration Number: DE0503764
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Product Description

The devices are non-active implants intended to provide temporary stabilization for bones or bone fragments. The MICA® Screw implants are indicated for the fixation and stabilization of elective osteotomy or arthrodesis procedures of the forefoot bones.

Device Classification
Device Class
CLASS C
Medical Speciality Area
Orthopaedics
Registration Information
Registration Number
DE0503764
Registration Date
October 23, 2019
Change Notification Approval Date
September 16, 2024
Retention Due Date
October 22, 2025
Product Owner
Short Name
Wright Medical Technology Inc.
Address
1023 Cherry Road, Memphis, TN 38117, UNITED STATES
Registrant
Address
1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Importer
Address
47 JALAN BUROH, #09-01, SINGAPORE 619491 1 GEORGE STREET, ONE GEORGE STREET, #20-1/2/3, SINGAPORE 049145
Model Information
Model Name(s)
MICA Cannulated Drill Bit MICA Cannulated Drill Bit PROSTEP MICA Depth Gauge MICA Drill Bit MICA Drill Bit PROSTEP MICA Drill Sleeve MICA Cannulated Countersink MICA Hex Driver Hex MICA Hex Driver Hex PROSTEP MICA Solid Drill Bit MIS Sterile Instrument Pack PROSTEP MICA Target Guide Pack PROSTEP MICA First Met Translator MICA SCREW 3MM X 20MM MICA SCREW 3MM X 22MM MICA SCREW 3MM X 24MM MICA SCREW 3MM X 26MM MICA SCREW 3MM X 28MM MICA SCREW 3MM X 30MM MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw AO Cannulated Handle PROSTEP MIS Sterile Instrument Pack w/Blade PROSTEP MIS Sterile Instrument Pack w/Blade & Burr MICA SCREW 4MM X 20MM MICA SCREW 4MM X 22MM MICA SCREW 4MM X 24MM MICA SCREW 4MM X 26MM MICA SCREW 4MM X 28MM MICA SCREW 4MM X 30MM MICA SCREW 4MM X 32MM MICA SCREW 4MM X 34MM MICA SCREW 4MM X 36MM MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Screw MICA Burr MICA Burr PROSTEP MICA cutting burr MICA Burr MICA Burr MICA Wedge Burr MICA Wedge Burr
Model Identifier(s)
57S00022 57S00030 57S000DG 57S00122 57S00130 57S00222 57S01040 57S02020 57S02025 57S0L122 57S0MI06 57S10013 57S100MT 57S13020 57S13022 57S13024 57S13026 57S13028 57S13030 57S13032 57S13034 57S13036 57S13038 57S13040 57S13042 57S13044 57S13046 57S13048 57S1HNDL 57S1MI07 57S1MI08 57S34020 57S34022 57S34024 57S34026 57S34028 57S34030 57S34032 57S34034 57S34036 57S34038 57S34040 57S34042 57S34044 57S34046 57S34048 57S34050 57S34052 57S34054 57S34056 57S34058 57S34060 57SC0208 57SC0320 57SC320L 57SR0212 57SR0220 57SW3113 57SW4113