Medical Device Division · registration 100217ActiveSmith & Nephew
Hong KongOrthopedic Internal Fixation SystemsClass IIISmith & Nephew Inc.
Official record identity
- MDACS listing number
- 100217
- Model name
- EndoButton CL Ultra (72200146, 72200147, 72200148, 72200149, 72200150, 72200151, 72200152, 72200153, 72200154, 72200155), EndoButton CL-BTB (7210080, 7210081, 7210082, 7210083, 7210084, 7210085, 7210086, 7210087, 7210088), XTENDOBUTTON Fixation Device (72200134), EndoButton Fixation Button (013186)
- Registration date
- February 14, 2025
- Expiry date
- June 29, 2030
- Source update date
- August 20, 2026
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Smith & Nephew Limited
- Manufacturer
- Smith & Nephew Inc.
Official description
Orthopedic Internal Fixation Systems
Additional source fields
- AMD nomenclature code
- 16027
- Traditional Chinese local responsible person
- 施樂輝有限公司
- Local responsible person phone
- 26487700
- Published manufacturer address
- Endoscopy, 150 Minuteman Road, Andover, Massachusetts, 01810, USA
- Revision number
- d
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.