FDA.reportPublic FDA data

MSS - Humeral reverse liners

Primary DI
07630542751134
Brand
MSS - Humeral reverse liners
Company
Medacta International SA
Model
04.01.0516
Device description
Hum. rev. constrained E-CROSS liner Ø39/+6
Published
2025-11-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true

Product Codes#

Code, Name table
CodeName
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250338000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250338000MSS - Humeral reverse liners extensionMedacta International S.A.2025-10-31PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630542751134PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542751134076305427511347630542751134

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene reverse shoulder prosthesis cupA sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to a humeral stem prosthesis, or humeral body component, and to articulate with the reverse shoulder head.

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
07630345775320Shoulder System04.01.10.06972026-09-28
07630345775375Shoulder System04.01.10.07022026-09-28
07630542727528Shoulder System04.01.10.08812026-09-28
07630542727535Shoulder System04.01.10.08822026-09-28
07630542727542Shoulder System04.01.10.08832026-09-28
07630542727559Shoulder System04.01.10.08842026-09-28
07630542794964Surgical Manual Instrument04.01.10.10132026-09-28
07630542794971Surgical Manual Instrument04.01.10.10142026-09-28
07630542794988Surgical Manual Instrument04.01.10.10152026-09-28
07630542794995Surgical Manual Instrument04.01.10.10162026-09-28
07630542795008Shoulder System04.01.10.10172026-09-28
07630542795015Shoulder System04.01.10.10182026-09-28
07630542795022Shoulder System04.01.10.10192026-09-28
07630542795039Shoulder System04.01.10.10202026-09-28
07630542795046Shoulder System04.01.10.10212026-09-28
07630542795053Shoulder System04.01.10.10222026-09-28
07630542795060Shoulder System04.01.10.10232026-09-28
07630542795077Shoulder System04.01.10.10242026-09-28
07630542795084Shoulder System04.01.10.10252026-09-28
07630542795091Shoulder System04.01.10.10262026-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345775320Shoulder SystemMedacta International SAPHX2026-09-28
07630345775375Shoulder SystemMedacta International SAPHX2026-09-28
07630542727528Shoulder SystemMedacta International SAPHX2026-09-28
07630542727535Shoulder SystemMedacta International SAPHX2026-09-28
07630542727542Shoulder SystemMedacta International SAPHX2026-09-28
07630542727559Shoulder SystemMedacta International SAPHX2026-09-28
07630542795008Shoulder SystemMedacta International SAPHX2026-09-28
07630542795015Shoulder SystemMedacta International SAPHX2026-09-28
07630542795022Shoulder SystemMedacta International SAPHX2026-09-28
07630542795039Shoulder SystemMedacta International SAPHX2026-09-28
07630542795046Shoulder SystemMedacta International SAPHX2026-09-28
07630542795053Shoulder SystemMedacta International SAPHX2026-09-28
07630542795060Shoulder SystemMedacta International SAPHX2026-09-28
07630542795077Shoulder SystemMedacta International SAPHX2026-09-28
07630542795084Shoulder SystemMedacta International SAPHX2026-09-28
07630542795091Shoulder SystemMedacta International SAPHX2026-09-28
07630542795107Shoulder SystemMedacta International SAPHX2026-09-28
07630542795114Shoulder SystemMedacta International SAPHX2026-09-28
07630542795121Shoulder SystemMedacta International SAPHX2026-09-28
07630542795138Shoulder SystemMedacta International SAPHX2026-09-28
07630542795145Shoulder SystemMedacta International SAPHX2026-09-28
07630542795152Shoulder SystemMedacta International SAPHX2026-09-28
07630542795169Shoulder SystemMedacta International SAPHX2026-09-28
07630542795176Shoulder SystemMedacta International SAPHX2026-09-28
07630542795183Shoulder SystemMedacta International SAPHX2026-09-28
07630542795190Shoulder SystemMedacta International SAPHX2026-09-28
07630542795206Shoulder SystemMedacta International SAPHX2026-09-28
07630542795213Shoulder SystemMedacta International SAPHX2026-09-28
07630542795220Shoulder SystemMedacta International SAPHX2026-09-28
07630542795237Shoulder SystemMedacta International SAPHX2026-09-28