510(k) clearances

ARENAL Anterior Cervical Plate System

Effortmed, LLC · Orthopedic

K240935Substantially EquivalentTraditionalKWQ
Open FDA's page for this record
Third party flag
N
City
Coral Springs
Advisory committee description
Orthopedic
Address 1
4766 NW 91st Way
Statement or summary
Summary
Product code
KWQ
Zip code
33067
Applicant
Effortmed, LLC
Decision date
2024-05-17
Decision code
SESE
Country code
US
Device name
ARENAL Anterior Cervical Plate System
Advisory committee
OR
Contact
Steven Brown
K number
K240935
State
FL
Date received
2024-04-05
Review advisory committee
OR
Postal code
33067
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.