Pure Global AI
Medical Device Division · registration 210073Active

Globus Medical

Hong KongOrthopedic Internal Fixation Systems, SpinalClass IIIGlobus Medical, Inc.
Official record identity
MDACS listing number
210073
Model name
REFLECT Scoliosis Correction System (1140.1125S, 1140.1250S, 1140.1251S, 1140.1350S, 1140.1351S, 1140.1500S, 1140.1501S, 1140.1750S, 1140.1751S, 1140.1800S, 4140.0125S, 4140.0126S, 4140.0250S, 4140.0350S, 4140.0500S, 4140.0750S, 6041.4304S, 6041.4313S, 6041.4314S, 602.117, 6041.0240, 6041.0245, 6041.0250, 6041.0255, 6041.0260, 6041.0265, 6041.4002, 6067.0526, 629.101, 629.102, 629.103, 629.104, 629.105, 629.106, 629.107, 630.407, 643.110, 676.600, 6041.0510, 6041.0604, 6041.4001, 6041.4003, 6041.4004, 6041.4006, 6041.4008, 6041.4011, 6041.4013, 6041.4304, 6041.4305, 6041.4306, 6041.4307, 6041.4308, 6041.4312, 6041.4313, 6041.4314, 6041.4317, 6067.0056, 6067.0057, 6067.0062, 6067.1015, 6067.3031, 6067.3036, 929.008, 929.009, 9041.1000, 9067.0004, 9067.0801, 9067.0802, 9067.0803, 9067.0804, 9140.0005), CREO Stabilization System (1067.2205, 1119.2205, 1067.0000, 1067.0000S, 1119.0001, 1119.0001S, 5067.0110, 5067.0111, 5067.0112, 5067.0120, 5067.0125, 5067.0130, 5067.0135, 5067.0140, 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5119.4026, 5119.4027, 5119.4028, 5119.4029, 5119.4030, 5119.4031, 5119.4032, 5119.4033, 5119.4034, 5119.4035, 5119.4036, 5119.4037, 5119.4038, 5119.4039, 5119.4040, 5119.4041, 5119.4042, 5119.4043, 5119.4044, 5119.4045, 5119.4046, 5119.4047, 5119.4048, 5119.4049, 5119.4050, 5119.4051, 5119.4052, 5119.4053, 5119.4054, 5119.4055, 5119.4056, 5119.4057, 5119.4058, 5119.4059, 5119.4060, 5119.4061, 5119.4062, 5119.4063, 5119.4064, 5119.4065, 5119.4066, 5119.4067, 5119.4068, 5119.4069, 5119.4070, 5119.4071, 5119.4072, 5119.4073, 5119.4074, 5119.4075, 5119.4076, 5119.4077, 5119.4078, 5119.4079, 5119.4080), GATEWAY Thoracolumbar Plate System (129.6000, 129.6010, 129.6020, 129.6030, 129.6040, 129.6050, 129.6060, 129.6070, 129.600S, 129.601S, 129.602S, 129.603S, 129.604S, 129.605S, 129.606S, 129.607S)
Registration date
October 16, 2025
Expiry date
February 21, 2031
Source update date
October 20, 2025
Status
Active
Official value: Valid
Classification
Risk class
Class III
Official value: III
Published category
Orthopedic Internal Fixation Systems, Spinal
Published parties
Registrant / registration holder
Asia Actual Limited
Official description

Orthopedic Internal Fixation Systems, Spinal

Additional source fields
AMD nomenclature code
15766
Local responsible person phone
28933118
Published manufacturer address
Valley Forge Business Center, 2560 General Armistead Avenue, Audubon, PA, 19403, United States of America
Revision number
a
About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.