510(k) clearances

Locking Plates and Screws Systems

Hebei Ruihe Medical Devices Co., Ltd. · Orthopedic

K240958Substantially EquivalentAbbreviatedHRS
Open FDA's page for this record
Third party flag
N
City
Shijiazhuang
Advisory committee description
Orthopedic
Address 1
# 599 Qinling St.
Address 2
High-Tech Industrial Development Zone
Statement or summary
Summary
Product code
HRS
Zip code
051430
Applicant
Hebei Ruihe Medical Devices Co., Ltd.
Decision date
2025-02-10
Decision code
SESE
Country code
CN
Device name
Locking Plates and Screws Systems
Advisory committee
OR
Contact
Mengjia Chi
K number
K240958
Date received
2024-04-08
Review advisory committee
OR
Postal code
051430
Decision description
Substantially Equivalent
Clearance type
Abbreviated
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.