510(k) clearances

Arthrex Humeral Plating System and Cerclage Button

Arthrex, Inc. · Orthopedic

K243995Substantially EquivalentTraditionalHRS
Open FDA's page for this record
Third party flag
N
City
Naples
Advisory committee description
Orthopedic
Address 1
1370 Creekside Blvd.
Statement or summary
Summary
Product code
HRS
Zip code
34108
Applicant
Arthrex, Inc.
Decision date
2025-03-26
Decision code
SESE
Country code
US
Device name
Arthrex Humeral Plating System and Cerclage Button
Advisory committee
OR
Contact
Ivette Galmez
K number
K243995
State
FL
Date received
2024-12-26
Review advisory committee
OR
Postal code
34108
Decision description
Substantially Equivalent
Clearance type
Traditional
Harmonized identifiers (openFDA)
Device name
Plate, Fixation, Bone
Medical specialty description
Orthopedic
Regulation number
888.3030
Device class
2
Registration number
3011580264, 1226544, 3023265483, 9614438, 3007051929, 3006801265, 3010047402, 3007993775, 3013280419, 3038503572, 3014527928, 3019923333, 1058084, 3010400367, 9615766, 3010470577, 2032830, 3004187715, 3022777867, 3021336182, 2031009, 3015869121, 3011230048, 3043543260, 3011295718, 3026576110, 3010375065, 3010646402, 2531477, 3036756245, 3034676720, 1218017, 3010039400, 3013540005, 3011127597, 1828288, 1038671, 3005751028, 3027242374, 3009756327 +481 more
FEI number
3011580264, 3023265483, 3007051929, 3006801265, 3010047402, 3007993775, 1000139987, 1000069183, 3013280419, 3038503572, 3007282753, 3014527928, 3019923333, 3002807231, 3002808264, 1000143502, 3003690049, 3010400367, 3010470577, 3004187715, 3022777867, 3008782585, 3021336182, 3015869121, 3011230048, 3043543260, 3011295718, 3026576110, 3010375065, 3010646402, 3002821504, 3036756245, 3034676720, 1218017, 3010039400, 3013540005, 3011127597, 1828288, 1038671, 3005751028 +481 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.