MedalOne Total Knee System
Suzhou Microport Orthorecon Co., Ltd. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Suzhou
- Advisory committee description
- Orthopedic
- Address 1
- Bldg. 2 And 3, #151, Fengli St., Suzhou Industrial
- Address 2
- Park Pilot Free Trade Zone Suzhou District
- Statement or summary
- Summary
- Product code
- JWH
- Zip code
- 215000
- Applicant
- Suzhou Microport Orthorecon Co., Ltd.
- Decision date
- 2025-02-28
- Decision code
- SESE
- Country code
- CN
- Device name
- MedalOne Total Knee System
- Advisory committee
- OR
- Contact
- Qingling Bao
- K number
- K244039
- Date received
- 2024-12-30
- Review advisory committee
- OR
- Postal code
- 215000
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3560
- Device class
- 2
- Registration number
- 1422549, 3003916006, 1226544, 3004450489, 3002806603, 3006801265, 3013280419, 3006946276, 3009871135, 3004153240, 3010400367, 3006563559, 3011295718, 3010375065, 3010370880, 2531477, 3036756245, 3034676720, 3010039400, 1219655, 1828288, 1038671, 3005751028, 3009882462, 3005652161, 3015978338, 3016096064, 3007913880, 3010576282, 3013176080, 3008021110, 3007963827, 3010132111, 2030624, 3005551626, 3002808022, 3011461101, 3008110533, 3010363503, 1047843 +282 more
- FEI number
- 3003916006, 3004450489, 3002806603, 3006801265, 3013280419, 1000139987, 3006946276, 1000199976, 3007282753, 1000143502, 3005568854, 3009871135, 3004153240, 3010400367, 3006563559, 3011295718, 3010375065, 3010370880, 3036756245, 3034676720, 3010039400, 3003142829, 1219655, 1828288, 1038671, 1000118610, 3005751028, 3002808402, 3009882462, 3005652161, 3015978338, 3016096064, 3007913880, 3010576282, 3013176080, 3008021110, 3007963827, 3010132111, 3005551626, 3002808022 +282 more