FDA.reportPublic FDA data

Mpres Neck Preserving Stem

Primary DI
07630345713582
Brand
Mpres Neck Preserving Stem
Company
Medacta International SA
Model
01.37.032
Device description
Mpres LAT #12
Published
2021-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, Uncemented
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium Phosphate

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LZOProsthesis, Hip, Semi-Constrained, Metal/Ceramic/Polymer, Cemented Or Non-Porous, UncementedOrthopedic2
MEHProsthesis, Hip, Semi-Constrained, Uncemented, Metal / Polymer, Non-Porous, Calcium PhosphateOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K210263000
K250450000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K210263000Mpres Neck Preserving StemMedacta International S.A.2021-09-22LZO
K250450000Coated hip implantsMedacta International S.A.2025-09-19LZO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630345713582PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630345713582076303457135827630345713582

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07630699714822Surgical Manual Instrument01.24.10.5052026-11-03
07630699700689Knee Instruments02.15.10.01452026-10-29
07630699705240Surgical Manual Instrument03.22.10.11652026-10-21
07630699705257Surgical Manual Instrument03.22.10.11662026-10-21
07630699705264Surgical Manual Instrument03.22.10.12672026-10-21
07630699705271Surgical Manual Instrument03.22.10.12682026-10-21
07630542720680Surgical Manual Instrument03.22.10.10572026-10-14
07630542720895Surgical Manual Instrument03.22.10.11122026-10-14
07630542721045Surgical Manual Instrument03.22.10.11142026-10-14
07630542721052Surgical Manual Instrument03.22.10.11172026-10-14
07630542721069Surgical Manual Instrument03.22.10.11182026-10-14
07630542721304Surgical Manual Instrument03.22.10.12422026-10-14
07630542721311Surgical Manual Instrument03.22.10.12432026-10-14
07630542721335Surgical Manual Instrument03.22.10.13422026-10-14
07630699705950Shoulder System04.01.10.12142026-10-01
07630699705967Shoulder System04.01.10.12152026-10-01
07630699705974Shoulder System04.01.10.12162026-10-01
07630699705998Shoulder System04.01.10.12182026-10-01
07630699706001Shoulder System04.01.10.12192026-10-01
07630699706018Shoulder System04.01.10.12202026-10-01

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