510(k) clearances

EVOS Pelvic and Acetabular System

Smith & Nephew · Orthopedic

K241666Substantially EquivalentTraditionalHRS
Open FDA's page for this record
Third party flag
N
City
Memphis
Advisory committee description
Orthopedic
Address 1
1450 Brooks Rd.
Statement or summary
Summary
Product code
HRS
Zip code
38116
Applicant
Smith & Nephew
Decision date
2025-02-19
Decision code
SESE
Country code
US
Device name
EVOS Pelvic and Acetabular System
Advisory committee
OR
Contact
Mandy Coe
K number
K241666
State
TN
Date received
2024-06-10
Review advisory committee
OR
Postal code
38116
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.