Fule Vertebroplasty Balloon Catheter
Beijing Fule Science & Technology Development Co., Ltd. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Beijing
- Advisory committee description
- Orthopedic
- Address 1
- #50, Mafang W. Industry Zone, Pinggu District
- Statement or summary
- Summary
- Product code
- HRX
- Zip code
- 101204
- Applicant
- Beijing Fule Science & Technology Development Co., Ltd.
- Decision date
- 2026-08-28
- Decision code
- SESE
- Country code
- CN
- Device name
- Fule Vertebroplasty Balloon Catheter
- Advisory committee
- OR
- Contact
- Xiaoliang Chen
- K number
- K260203
- Date received
- 2026-01-23
- Review advisory committee
- OR
- Postal code
- 101204
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Arthroscope
- Medical specialty description
- Orthopedic
- Regulation number
- 888.1100
- Device class
- 2
- Registration number
- 1221934, 3013176080, 3003678543, 3003902757, 3006849754, 2029275, 3004111573, 3006787036, 3012447612, 2648623, 3012322232, 3018242561, 1836161, 3009538961, 2032098, 3009499159, 3012790575, 2434839, 3007955117, 8030607, 3014479313, 3013944123, 3044858680, 3012818475, 3015542154, 1526611, 3009417901, 3012358417, 3035858921, 1061124, 3009475067, 1064017, 2919128, 1320894, 3030153385, 2020601, 1055236, 3016789487, 1221826, 1222997 +349 more
- FEI number
- 1221934, 3013176080, 3003678543, 3003902757, 3006849754, 3006787036, 3004111573, 3002808445, 3012447612, 2648623, 3003276727, 3012322232, 3018242561, 3003110144, 3009538961, 1000112877, 1000160458, 3000219468, 3006149253, 3009499159, 3012790575, 3002806588, 3003448211, 2434839, 3007955117, 3014479313, 3013944123, 3000215273, 3044858680, 3012818475, 3015542154, 1526611, 3009417901, 3012358417, 3035858921, 3009475067, 3003640911, 2919128, 3030153385, 2020601 +349 more