FDA.reportPublic FDA data

SMR System

Primary DI
08033390272513
Brand
SMR System
Company
LIMACORPORATE SPA
Model
1352.15.001
Catalog number
1352.15.001
Device description
SMR System - Extension for Humeral Reverse Body
Published
2024-02-22
Public version status
New
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
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110598000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110598000SMR REVERSE SHOULDER SYSTEMLima Corporate S.P.A.2011-08-18PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390272513PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390272513080333902725138033390272513

GMDN Terms#

Term, Definition table
TermDefinition
Humeral body extension prosthesisA sterile implantable component of a reverse shoulder prosthesis that consists of a metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] piece intended to function as a spacer between a reverse shoulder body prosthesis and a reverse shoulder cup prosthesis.

Regulatory Flags#

DUNS number
432066322
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08033390201858Smart SPACE SHOULDER0023.L1.N330023.L1.N332023-02-18
08033390201872Smart SPACE SHOULDER0023.L2.N330023.L2.N332023-02-18
08033390201896Smart SPACE SHOULDER0023.L3.N330023.L3.N332023-02-18
08033390201919Smart SPACE SHOULDER0023.R1.N330023.R1.N332023-02-18
08033390201933Smart SPACE SHOULDER0023.R2.N330023.R2.N332023-02-18
08033390201957Smart SPACE SHOULDER0023.R3.N330023.R3.N332023-02-18
08033390239509Smart SPACE SHOULDER0023.R4.N330023.R4.N332023-02-18
08033390239516Smart SPACE SHOULDER0023.L4.N330023.L4.N332023-02-18
08033390216036SMR Shoulder1379.5G.0301379.5G.0302026-05-11
08033390216043SMR Shoulder1379.5G.1201379.5G.1202026-05-11
08033390216050SMR Shoulder1379.5G.1241379.5G.1242026-05-11
08033390216067SMR Shoulder1379.5G.3201379.5G.3202026-05-11
08033390216074SMR Shoulder1379.5G.3221379.5G.3222026-05-11
08033390216081SMR Shoulder1379.5G.3241379.5G.3242026-05-11
08033390216098SMR Shoulder1379.5G.3301379.5G.3302026-05-11
08033390272797SMR System1375.15.6051375.15.6052026-02-25
08033390272803SMR System1375.15.6101375.15.6102026-02-25
08033390272810SMR System1375.15.6201375.15.6202026-02-25
08033390002233SMR System1362.09.0101362.09.0102026-02-19
08033390002240SMR System1362.09.0151362.09.0152026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630699705950Shoulder SystemMedacta International SAPHX2026-10-01
07630699705967Shoulder SystemMedacta International SAPHX2026-10-01
07630699705974Shoulder SystemMedacta International SAPHX2026-10-01
07630699705998Shoulder SystemMedacta International SAPHX2026-10-01
07630699706001Shoulder SystemMedacta International SAPHX2026-10-01
07630699706018Shoulder SystemMedacta International SAPHX2026-10-01
07630699706032Shoulder SystemMedacta International SAPHX2026-10-01
07630699706049Shoulder SystemMedacta International SAPHX2026-10-01
07630699706056Shoulder SystemMedacta International SAPHX2026-10-01
B1132R2HC300100Shoulder Innovations RSA Glenosphere Trial Instrument CaseShoulder Innovations, Inc.PHX2026-09-30
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