510(k) clearances

DePuy Synthes MatrixSTERNUM Fixation System

Synthes GmbH · Orthopedic

K233967Substantially EquivalentTraditionalHRS
Open FDA's page for this record
Third party flag
N
City
Zuchwil
Advisory committee description
Orthopedic
Address 1
Luzernstrasse 21
Statement or summary
Summary
Product code
HRS
Zip code
4528
Applicant
Synthes GmbH
Decision date
2024-05-09
Decision code
SESE
Country code
CH
Device name
DePuy Synthes MatrixSTERNUM Fixation System
Advisory committee
OR
Contact
Georgina Mueller
K number
K233967
Date received
2023-12-15
Review advisory committee
OR
Postal code
4528
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.