MONDRIAN Anterior Lumbar Plate System
Ctl Medical Corporation · Orthopedic
Open FDA's page for this record- Third party flag
- N
- City
- Addison
- Advisory committee description
- Orthopedic
- Address 1
- 4550 Excel Pkwy.
- Address 2
- Suite 300
- Statement or summary
- Summary
- Product code
- KWQ
- Zip code
- 75001
- Applicant
- Ctl Medical Corporation
- Decision date
- 2024-01-26
- Decision code
- SESE
- Country code
- US
- Device name
- MONDRIAN Anterior Lumbar Plate System
- Advisory committee
- OR
- Contact
- Sean Suh
- K number
- K231715
- State
- TX
- Date received
- 2023-06-13
- Review advisory committee
- OR
- Postal code
- 75001
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Appliance, Fixation, Spinal Intervertebral Body
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3060
- Device class
- 2
- Registration number
- 9617297, 1226544, 3007993775, 3007485169, 3006846753, 3011221483, 3010866843, 3009554293, 3005819474, 3015991317, 3015869121, 3043543260, 3010370880, 2531477, 3036756245, 3006404019, 3034676720, 3011127597, 1828288, 3011556898, 3015941638, 3024999441, 3009756327, 3016112537, 3008526708, 3006217744, 3016443334, 3010120326, 3004893332, 2531195, 2530808, 2028632, 3015869492, 3010041993, 1043214, 3010120135, 3008110533, 3009169872, 3010363503, 3007289746 +326 more
- FEI number
- 3000718490, 3007993775, 1000139987, 1000069183, 3007485169, 3006846753, 3011221483, 1000143502, 3010866843, 3009554293, 3005532635, 3005819474, 3003112432, 3015991317, 3015869121, 3043543260, 3010370880, 3036756245, 3034676720, 3011127597, 1828288, 3011556898, 3024999441, 3016112537, 3008526708, 1000514656, 3006217744, 3016443334, 3010120326, 3004893332, 3002980729, 1000219637, 3015869492, 3010041993, 1000522098, 1043214, 3010120135, 3008110533, 3009169872, 3010363503 +326 more