Pure Global
Singapore HSA registration DE0510380

IsoTis OrthoBiologics OsteoStrux® Putty Osteoconductive Scaffold

Singapore flagSingapore·CLASS D·IsoTis OrthoBiologics, Inc·Registered February 24, 2025
Device classification
Device Class
CLASS D
Medical Speciality Area
General Hospital
Registration information
Registration Number
DE0510380
Registration Date
February 24, 2025
Retention Due Date
February 23, 2026
Product description
OsteoStrux Putty, combined with bone marrow aspirate, is intended for use as a bone void filler to fill voids or gaps of the skeletal system in the extremities, spine, and pelvis not intrinsic to the stability of the bony structure. OsteoStrux Putty is also indicated for use in the treatment of surgically treated osseous defects or osseous defects created from traumatic injury to the bone. Following placement in the bony void or gap (defect), OsteoStrux Putty is resorbed and replaced with bone during the healing process.
Product Owner
Name
IsoTis OrthoBiologics, Inc
Short Name
IsoTis OrthoBiologics, Inc
Address
2 Goodyear, Irvine, CA 92618, UNITED STATES
Registrant
Name
DTG MEDICAL PTE LTD
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #06-03, SINGAPORE 119968
Importer
Name
DTG MEDICAL PTE LTD
Address
438B ALEXANDRA ROAD, ALEXANDRA TECHNOPARK, #06-03, SINGAPORE 119968
Model information
Model Name(s)
OsteoStrux CCM Putty, 2.5cc OsteoStrux CCM Putty, 5cc OsteoStrux CCM Putty, 10cc OsteoStrux CCM Putty, 15cc
Model Identifier(s)
56070025 56070050 56070100 56070150
About this record

Access comprehensive regulatory information for IsoTis OrthoBiologics OsteoStrux® Putty Osteoconductive Scaffold in the Singapore medical device market through Pure Global AI's free database. This CLASS D medical device is registered under HSA registration number DE0510380 and owned by IsoTis OrthoBiologics, Inc. The device was registered on February 24, 2025.

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 DatabasePowered by Pure Global AIHSA Official DataCLASS D