Medical Device Division · registration 210412ActiveMedtronic Sofamor Danek USA
Hong KongOrthopedic Internal Fixation Systems, SpinalClass IIIMedtronic Sofamor Danek USA, Inc.
Official record identity
- MDACS listing number
- 210412
- Model name
- Elevate Spinal System (1850077, 1850079, 7770723, 7770728, 7770732, 7770823, 7770828, 7770832, 7770923, 7770928, 7770932, 7771023, 7771028, 7771032, 7771123, 7771128, 7771132, 8657001, 8657002, 8657003, 8657005, 8657006, 8657007, 8657008, 8657011, 8657012, 8657013, 8657017, 8657018, 8880823, 8880828, 8880832, 8880923, 8880928, 8880932, 8881023, 8881028, 8881032, 8881123, 8881128, 8881132), Navigated Disc Prep Instrument Set (NAV2054, NAV2055, NAV2056, NAV2057, NAV2058, NAV2059, NAV2060, NAV2061, NAV2062, NAV2063, NAV2064, NAV2065, NAV2137, NAV2139, NAV2141, NAV2142)
- Registration date
- June 18, 2026
- Expiry date
- January 16, 2032
- Status
- Active
Official value: Valid
Classification
- Risk class
- Class III
Official value: III
Published parties
- Registrant / registration holder
- Medtronic Hong Kong Medical Limited
- Manufacturer
- Medtronic Sofamor Danek USA, Inc.
Official description
Orthopedic Internal Fixation Systems, Spinal
Additional source fields
- AMD nomenclature code
- 15766
- Traditional Chinese local responsible person
- 美敦力香港醫療有限公司
- Local responsible person phone
- 29191300
- Published manufacturer address
- 1800 Pyramid Place, Memphis, TN 38132, USA
- 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.