FDA.reportPublic FDA data

SMR System

Primary DI
08033390002233
Brand
SMR System
Company
LIMACORPORATE SPA
Model
1362.09.010
Catalog number
1362.09.010
Device description
SMR System - Reverse HP Liner Short Dia. 44mm
Published
2026-02-19
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
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K252352000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K252352000SMR Shoulder System; PRIMA Glenoid System; PRIMA Humeral SystemLima Corporate S.P.A.2026-01-22PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08033390002233PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390002233080333900022338033390002233

GMDN Terms#

Term, Definition table
TermDefinition
Metallic reverse shoulder prosthesis cupA sterile component of a reverse shoulder prosthesis that consists of a metal cup intended to be attached to either a humeral stem prosthesis or humeral body component, and to articulate with the reverse shoulder head.

Device Sizes#

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

Sterilization Methods#

Method table
Method

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
08033390002240SMR System1362.09.0151362.09.0152026-02-19
08033390002257SMR System1362.09.0201362.09.0202026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868552113Signature ONE Software PackageOrthosoft IncMBF2026-10-27
00887868552113Signature ONE Software PackageOrthosoft IncPHX2026-10-27
B1132N1HI000010Shoulder Innovations Humeral Short Stem SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN140380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN150520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN160380Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN160420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN170400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN170440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN180400Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN180420Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN180440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN180460Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN180480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN180520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN180560Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN190440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN190500Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN200460Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN200480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN200520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN210440Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN210480Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN210500Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN210520Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
B1132N2HN210560Shoulder Innovations Total Shoulder SystemShoulder Innovations, Inc.MBF2026-10-23
00840097503677Veritas InstrumentationRestor3d, Inc.PHX2026-10-16