FDA.reportPublic FDA data

NEXUS

Primary DI
M684NEXHNC111
Brand
NEXUS
Company
Microport Orthopedics Inc.
Model
NEXHNC11
Catalog number
NEXHNC11
Device description
NEXUS FEMORAL STEM HIGH OFFSET COLLARLESS SZ 11
Published
2025-07-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
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
00192629402652PrimaryGS10
M684NEXHNC111SecondaryHIBCC0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00192629402652001926294026521926294026520192629402652

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
079118736
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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