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510(k) clearances

NEXUS® Hip Stem

Microport Orthopedics, Inc. · Orthopedic

K262473Substantially EquivalentSpecialLZO
Open FDA's page for this record
Third party flag
N
City
Arlington
Advisory committee description
Orthopedic
Address 1
5677 Airline Rd.
Statement or summary
Summary
Product code
LZO
Zip code
38002
Applicant
Microport Orthopedics, Inc.
Decision date
2026-10-01
Decision code
SESE
Country code
US
Device name
NEXUS® Hip Stem
Advisory committee
OR
Contact
Hunter Williams
K number
K262473
State
TN
Date received
2026-07-17
Review advisory committee
OR
Postal code
38002
Decision description
Substantially Equivalent
Clearance type
Special
Harmonized identifiers (openFDA)
Device name
Prosthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
Medical specialty description
Orthopedic
Regulation number
888.3353
Device class
2
Registration number
3042508254, 1835251, 3016778562, 3012523063, 3006536454, 3013055499, 3021008900, 3010576282, 3005360851, 3016438694, 3008668801, 3004638532, 9681465, 3014763043, 1450662, 3026776, 3014273644, 2030624, 3000264985, 3010057495, 1226188, 3006801265, 3003387384, 3014315560, 3005333358, 3036773273, 3014252644, 3007334927, 9681642, 3008868758, 3005751028, 3016438761, 1061927, 3010039400, 3010314800, 3003639920, 2134285, 3003791208, 3006356043, 2249615 +238 more
FEI number
3042508254, 3016778562, 3012523063, 3006536454, 3013055499, 3021008900, 3010576282, 3005360851, 3016438694, 3008668801, 3004638532, 3002808293, 3014763043, 1450662, 3014273644, 3000264985, 3010057495, 3006801265, 3003387384, 3014315560, 3005601732, 3005333358, 3036773273, 3014252644, 3007334927, 3008868758, 3005751028, 3016438761, 3010039400, 3010314800, 3002807036, 3003639920, 3003791208, 3002924544, 3006356043, 1832656, 1000132037, 3007051929, 3001278222, 3011015572 +238 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.