Medical Device Division · registration 210071Active

Globus Medical

Name: Globus Medical — Medical Device Division 210071
Creator: Globus Medical, Inc.
Keywords: Globus Medical, Globus Medical, 210071, Bone Tamps, Inflatable, Medical Device Division

Hong KongBone Tamps, InflatableClass IIGlobus Medical, Inc.

Verified

Official record identity

MDACS listing number: 210071
Model name: AFFIRM VCF System (658.006S, 658.015S, 658.037S, 658.070S, 658.071S, 658.073S, 658.080S, 658.081S, 658.083S, 658.111S, 658.114S, 658.116S, 658.161S, 658.211S, 658.216S, 658.297S, 658.301S, 658.302S, 658.303S, 658.351S, 658.352S, 658.353S, 658.361S, 658.362S, 658.363S, 658.410S, 658.411S, 658.413S, 658.481S, 658.501S, 658.502S, 658.503S, 658.504S, 658.505S, 658.506S, 658.507S, 658.508S, 658.509S, 658.510S, 658.511S, 658.512S, 658.513S, 658.514S, 658.515S, 658.516S, 658.517S, 658.518S, 658.519S, 658.520S, 658.521S, 658.522S, 658.523S, 658.524S, 658.525S, 658.526S, 658.527S, 658.539S, 658.540S, 658.582S, 658.583S, 658.585S, 658.601S, 658.720S, 658.721S, 658.723S, 658.901S, 658.902S, 658.903S, 658.906S, 658.912S, 658.914S, 658.915S, 658.917S, 658.918S, 658.919S, 658.926S, 658.927S, 658.928S, 658.929S, 658.930S, 658.931S, 658.932S, 658.933S, 658.934S, 658.935S, 658.936S, 658.937S, 658.938S, 658.939S, 658.940S, 658.961S, 658.962S, 658.963S, 658.969S, 658.001, 658.007, 658.009, 958.001, 958.002, 958.008, 658.909S, 658.920S, 658.921S, 658.922S, 658.923S, 658.924S, 658.925S)
Registration date: October 16, 2025
Expiry date: February 21, 2031
Source update date: October 20, 2025
Status: Active

Classification

Risk class: Class II
Published category: Bone Tamps, Inflatable

Published parties

Registrant / registration holder: Asia Actual Limited
Manufacturer: Globus Medical, Inc.

Official description

Bone Tamps, Inflatable

Additional source fields

AMD nomenclature code: 22539
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.