510(k) clearances

icotec Anterior Cervical Plate System

Icotec AG · Orthopedic

K233215Substantially EquivalentTraditionalKWQ
Open FDA's page for this record
Third party flag
N
City
9450 Altstaetten (Sg)
Advisory committee description
Orthopedic
Address 1
Industriestrasse 12
Statement or summary
Summary
Product code
KWQ
Applicant
Icotec AG
Decision date
2024-05-17
Decision code
SESE
Country code
CH
Device name
icotec Anterior Cervical Plate System
Advisory committee
OR
Contact
Marina Hess
K number
K233215
Date received
2023-09-26
Review advisory committee
OR
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
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.