FDA.reportPublic FDA data

PRIMA

Primary DI
08033390202299
Brand
PRIMA
Company
LIMACORPORATE SPA
Model
1367.09.203
Catalog number
1367.09.203
Device description
PRIMA - Reverse Insert # MEDIUM Dia. 40mm 0°Corr.
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
08033390202299PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08033390202299080333902022998033390202299

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
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
08033390002257SMR System1362.09.0201362.09.0202026-02-19
08033390050029SMR System1362.09.1151362.09.1152026-02-19
08033390050036SMR System1362.09.1201362.09.1202026-02-19
08033390191135PRIMA1367.09.3761367.09.3762026-02-19
08033390201971PRIMA1367.09.2001367.09.2002026-02-19
08033390202305PRIMA1367.09.2061367.09.2062026-02-19
08033390202312PRIMA1367.09.2701367.09.2702026-02-19
08033390202466PRIMA1367.09.2731367.09.2732026-02-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08033390002233SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002240SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390002257SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050029SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390050036SMR SystemLIMACORPORATE SPAMBF2026-02-19
08033390115667SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390115698SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390115711SMR TT Hybrid GlenoidLIMACORPORATE SPAMBF2024-07-27
08033390108065SMR STEMLESSLIMACORPORATE SPAPHX2022-03-17
07613327507096REUNIONStryker GmbHPHX2021-11-02
07613327354317REUNIONStryker GmbHPHX2021-04-27
07613327354348REUNIONStryker GmbHPHX2021-04-27
07613327354362REUNIONStryker GmbHPHX2021-04-27
07613327354393REUNIONStryker GmbHPHX2021-04-27
07613327354409REUNIONStryker GmbHPHX2021-04-27
07613327354782REUNIONStryker GmbHPHX2021-04-27
07613327354812REUNIONStryker GmbHPHX2021-04-27
07613327354829REUNIONStryker GmbHPHX2021-04-27
07613327354836REUNIONStryker GmbHPHX2021-04-27
07613327354881REUNIONStryker GmbHPHX2021-04-27
07613327354911REUNIONStryker GmbHPHX2021-04-27
07613327354928REUNIONStryker GmbHPHX2021-04-27
07613327354959REUNIONStryker GmbHPHX2021-04-27
07613327354966REUNIONStryker GmbHPHX2021-04-27
07613327354973REUNIONStryker GmbHPHX2021-04-27
07613327354997REUNIONStryker GmbHPHX2021-04-27
07613327355000REUNIONStryker GmbHPHX2021-04-27
07613327355017REUNIONStryker GmbHPHX2021-04-27
07613327355031REUNIONStryker GmbHPHX2021-04-27
07613327355048REUNIONStryker GmbHPHX2021-04-27