Aevumed SUPERCYNCH Button System
Aevumed, Inc. · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Malvern
- Advisory committee description
- Orthopedic
- Address 1
- 109 Great Valley Pkwy.
- Statement or summary
- Summary
- Product code
- MBI
- Zip code
- 19355
- Applicant
- Aevumed, Inc.
- Decision date
- 2026-09-02
- Decision code
- SESE
- Country code
- US
- Device name
- Aevumed SUPERCYNCH Button System
- Advisory committee
- OR
- Contact
- Saif Khalil
- K number
- K253065
- State
- PA
- Date received
- 2025-09-22
- Review advisory committee
- OR
- Postal code
- 19355
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Fastener, Fixation, Nondegradable, Soft Tissue
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3040
- Device class
- 2
- Registration number
- 3011301313, 1835251, 1221934, 3013176080, 1417592, 3015718210, 3017210488, 3008599979, 1526711, 3021632375, 3044423486, 3006460162, 1834331, 3010047454, 1225492, 3010392243, 3038185071, 2029275, 3019269298, 3026368553, 3014560508, 2648623, 3010123256, 3015075784, 1226183, 3016851379, 3004365956, 3032412536, 3008110533, 1048735, 3010237768, 3009826895, 3003604053, 1319660, 1450662, 3024856795, 3012470322, 2936485, 3011061237, 3033273526 +238 more
- FEI number
- 3011301313, 1221934, 3013176080, 1417592, 3015718210, 3017210488, 3008599979, 1526711, 3021632375, 3044423486, 3006460162, 1317628, 3003056094, 3010047454, 3010392243, 3038185071, 1000116116, 3019269298, 3026368553, 3014560508, 3002757549, 2648623, 3004203341, 3010123256, 3015075784, 3016851379, 3004365956, 3032412536, 3002807113, 1000120613, 3008110533, 1048735, 3010237768, 3009826895, 3003604053, 1450662, 3024856795, 2936485, 3012470322, 3011061237 +238 more