FIX-C 3D Ti ACIF System
Jeil Medical Corporation · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Seoul
- Advisory committee description
- Orthopedic
- Address 1
- 702703704705706707804805807812815-Ho, 55
- Address 2
- Digital-Ro 34-Gil, Guro-Gu
- Statement or summary
- Summary
- Product code
- ODP
- Zip code
- 08378
- Applicant
- Jeil Medical Corporation
- Decision date
- 2025-02-18
- Decision code
- SESE
- Country code
- KR
- Device name
- FIX-C 3D Ti ACIF System
- Advisory committee
- OR
- Contact
- Jinwoo Kim
- K number
- K243915
- Date received
- 2024-12-20
- Review advisory committee
- OR
- Postal code
- 08378
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Intervertebral Fusion Device With Bone Graft, Cervical
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3080
- Device class
- 2
- Registration number
- 9617297, 3007604895, 1226544, 8010273, 3007993775, 3007485169, 3008864603, 3006846753, 3010866843, 3017065977, 1000493591, 3009554293, 3005819474, 3006563559, 3015991317, 3033739814, 3043543260, 3010375065, 3010646402, 2531477, 3036756245, 3010039400, 3016460869, 3011127597, 1836116, 1219655, 3011556898, 3015941638, 3005751028, 3024999441, 3009756327, 3016112537, 3009882462, 3031787625, 3023189283, 3008526708, 3006217744, 3016443334, 3023752918, 3010120326 +315 more
- FEI number
- 3000718490, 3007604895, 3007993775, 1000139987, 3007485169, 3008864603, 3006846753, 1000143502, 3010866843, 3017065977, 1000493591, 3009554293, 3005532635, 3005819474, 3006563559, 3003112432, 3015991317, 3033739814, 3043543260, 3010375065, 3010646402, 3036756245, 3010039400, 3003142829, 3011127597, 3016460869, 1219655, 1000118610, 3011556898, 3005751028, 3024999441, 3016112537, 3009882462, 3031787625, 3023189283, 3008526708, 1000518731, 3006217744, 3016443334, 3023752918 +315 more