FDA.reportPublic FDA data

Shoulder System

Primary DI
07630542714740
Brand
Shoulder System
Company
Medacta International SA
Model
04.01.0412
Device description
GRS baseplate 27 30 Full wedge 10
Published
2023-11-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
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
K231911000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231911000Glenoid Reconstruction System – Full Wedge BaseplateMedacta International S.A.2023-11-09PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07630542714740PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07630542714740076305427147407630542714740

GMDN Terms#

Term, Definition table
TermDefinition
Total shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
488227125
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
false
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
07630542779244Surgical Manual Instrument03.52.10.08042026-03-24
07630542715303Orthopedic Manual Surgical Instrument01.10.10.34592025-10-08
07630542715310Orthopedic Manual Surgical Instrument01.10.10.34602025-10-08
07630542715327Orthopedic Manual Surgical Instrument01.10.10.34612025-10-08
07630542715334Orthopedic Manual Surgical Instrument01.10.10.34622025-10-22
07630542789984Surgical Manual Instrument02.12.10.31252026-03-19
07630542789991Surgical Manual Instrument02.12.10.31262026-03-19
07630542797576Surgical Manual Instrument02.12.10.31422026-03-19
07630699705486Surgical Manual Instrument02.12.10.31622026-03-19
07630699705493Surgical Manual Instrument02.12.10.31632026-03-19
07630699705509Surgical Manual Instrument02.12.10.31642026-03-19
07630699705516Surgical Manual Instrument02.12.10.31652026-03-19
07630699705523Surgical Manual Instrument02.12.10.31662026-03-19
07630542725562Surgical Manual Instrument01.10.10.11602026-03-17
07630542791482Spine Instruments03.75.10.06612026-03-13
07630971230880Surgical Manual Instrument03.51.10.02342026-03-02
07630542790799Mfinity Femoral System01.24.10.3002026-02-27
07630542790805Mfinity Femoral System01.24.10.3012026-02-27
07630542790812Mfinity Femoral System01.24.10.3022026-02-27
07630542790829Mfinity Femoral System01.24.10.3032026-02-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033390002233SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390050029SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390050036SMR SystemLIMACORPORATE SPAPHX2026-02-19
08033390191135PRIMALIMACORPORATE SPAPHX2026-02-19
08033390201971PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202299PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202305PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202312PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202466PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202473PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202480PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202497PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202503PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202602PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202619PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202626PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202633PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202640PRIMALIMACORPORATE SPAPHX2026-02-19
08033390202657PRIMALIMACORPORATE SPAPHX2026-02-19
08033390248433PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248556PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248563PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248587PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248594PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248600PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248617PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248624PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19
08033390248631PRIMA TT GlenoidLIMACORPORATE SPAPHX2026-02-19