FDA.reportPublic FDA data

NEXUS

Primary DI
00192629402157
Brand
NEXUS
Company
Microport Orthopedics Inc.
Model
NEXSCL00
Catalog number
NEXSCL00
Device description
NEXUS FEMORAL STEM STANDARD OFFSET COLLARED SZ 0
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
LZOProsthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, uncemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250444000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250444000NEXUS® Hip StemMicroport Orthopedics, Inc.2025-05-15LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00192629402157PrimaryGS10
M684NEXSCL001SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629402157001926294021571926294021570192629402157

Contacts#

Phone, Email table
PhoneEmail
+1(866)872-0211Stephen.Weaver@ortho.microport.com

Regulatory Flags#

DUNS number
079118736
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00192629475007EVOLUTIONEIS1P11LEIS1P11L2026-11-03
00192629475014EVOLUTIONEIS1P13LEIS1P13L2026-11-03
00192629475021EVOLUTIONEIS1S11LEIS1S11L2026-11-03
00192629475038EVOLUTIONEIS1S13LEIS1S13L2026-11-03
00192629475045EVOLUTIONEIS2P11LEIS2P11L2026-11-03
00192629475052EVOLUTIONEIS2P13LEIS2P13L2026-11-03
00192629475069EVOLUTIONEIS2S11LEIS2S11L2026-11-03
00192629475076EVOLUTIONEIS2S13LEIS2S13L2026-11-03
00192629475083EVOLUTIONEIS3P11LEIS3P11L2026-11-03
00192629475090EVOLUTIONEIS3P13LEIS3P13L2026-11-03
00192629475106EVOLUTIONEIS3S11LEIS3S11L2026-11-03
00192629475113EVOLUTIONEIS3S13LEIS3S13L2026-11-03
00192629475120EVOLUTIONEIS4P11LEIS4P11L2026-11-03
00192629475137EVOLUTIONEIS4P13LEIS4P13L2026-11-03
00192629475144EVOLUTIONEIS4S11LEIS4S11L2026-11-03
00192629475151EVOLUTIONEIS4S13LEIS4S13L2026-11-03
00192629475168EVOLUTIONEIS5P11LEIS5P11L2026-11-03
00192629475175EVOLUTIONEIS5P13LEIS5P13L2026-11-03
00192629475182EVOLUTIONEIS5S11LEIS5S11L2026-11-03
00192629475199EVOLUTIONEIS5S13LEIS5S13L2026-11-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00889024713512G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713529G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713536G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713543G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713550G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713567G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713574G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713581G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713598G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713604G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713611G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713628G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713635G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713642G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713659G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713666G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713673G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713680G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713697G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713703G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713734G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713741G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713758G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713765G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713772G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713789G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713796G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713802G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713819G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03
00889024713826G7® TM Acetabular SystemZimmer, Inc.LZO2026-11-03