SCARLET® AC-Ti
Spineart SA · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Plan-Les-Ouates
- Advisory committee description
- Orthopedic
- Address 1
- Chemin Du Pré-Fleuri 3
- Statement or summary
- Summary
- Product code
- OVE
- Zip code
- 1228
- Applicant
- Spineart SA
- Decision date
- 2024-05-10
- Decision code
- SESE
- Country code
- CH
- Device name
- SCARLET® AC-Ti
- Advisory committee
- OR
- Contact
- Estelle Lefeuvre
- K number
- K240699
- Date received
- 2024-03-14
- Review advisory committee
- OR
- Postal code
- 1228
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Intervertebral Fusion Device With Integrated Fixation, Cervical
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3080
- Device class
- 2
- Registration number
- 3007766698, 9610612, 9617297, 3018094310, 1000432246, 3005739886, 3017521423, 3008868758, 3007604895, 8020776, 1057425, 8043792, 3015876273, 3015877656, 1226544, 2532027, 1724955, 3010047402, 3005180920, 3005706667, 3007125392, 3015212339, 3007993775, 3007485169, 2134285, 3009051471, 3008864603, 3005977257, 3009887475, 3019837678, 3006846753, 3030412764, 3003477135, 3015216945, 3010866843, 3013820501, 3009554293, 3033509898, 3008812560, 3006017180 +206 more
- FEI number
- 3007766698, 1000477302, 3018094310, 1000432246, 3000718490, 3017521423, 3008868758, 3007604895, 3005739886, 3015876273, 3015877656, 4224, 3001237338, 3003058119, 3010047402, 3005180920, 3005706667, 3007125392, 3015212339, 3007993775, 1000139987, 3002808269, 3007485169, 1000306303, 3009051471, 3008864603, 3005977257, 3009887475, 3019837678, 3011764740, 3006846753, 3003015552, 3030412764, 3003477135, 3015216945, 3002929183, 3010866843, 3003690049, 3013820501, 3009554293 +206 more