FDA.reportPublic FDA data

SMR Shoulder

Primary DI
08033390002011
Brand
SMR Shoulder
Company
LIMACORPORATE SPA
Model
Humeral Body
Catalog number
1350.15.020
Device description
Trauma humeral bodies with locking screw Long
Published
2015-07-29
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
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100858000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100858000LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL STEMS, LIMA-LIO SMR SHOULDER SYSTEM - HUMERAL BODIES,Lima-Lto S.P.A.2010-12-10KWT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390002011PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390002011080333900020118033390002011

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder humeral body prosthesisA sterile implantable component of a total shoulder prosthesis intended to form a connection between a humeral stem prosthesis and a humeral head prosthesis. It is made of metal [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)] or titanium (Ti)] and is used in a modular shoulder replacement system.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

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
00811596033460CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033477CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033484CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSHSD2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSKWT2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSHSD2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.HSD2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI208000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI226000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI228000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI240100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI246000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI248000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18