FDA.reportPublic FDA data

Identity® Shoulder System

Primary DI
00887868580758
Brand
Identity® Shoulder System
Company
Zimmer, Inc.
Model
110047345
Catalog number
110047345
Published
2024-09-09
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
Rx
true
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240876000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240876000Identity Shoulder SystemZimmer, Inc.2024-06-12MBF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868580758PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868580758008878685807588878685807580887868580758

GMDN Terms#

Term, Definition table
TermDefinition
Polyethylene reverse shoulder prosthesis cupA sterile component of a reverse shoulder prosthesis that consists of a polyethylene (PE) cup intended to be attached to 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

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
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
true
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
00887868150876Affixus®8151113008151113002026-03-20
00887868150333Affixus®8151103008151103002026-03-19
00887868150340Affixus®8151103208151103202026-03-19
00887868150357Affixus®8151103408151103402026-03-19
00887868150364Affixus®8151103608151103602026-03-19
00887868150371Affixus®8151103808151103802026-03-19
00887868150388Affixus®8151104008151104002026-03-19
00887868150395Affixus®8151104208151104202026-03-19
00887868150401Affixus®8151114208151114202026-03-19
00887868150555Affixus®8151123008151123002026-03-19
00887868150562Affixus®8151123208151123202026-03-19
00887868150579Affixus®8151123408151123402026-03-19
00887868150586Affixus®8151123608151123602026-03-19
00887868150593Affixus®8151123808151123802026-03-19
00887868150609Affixus®8151124008151124002026-03-19
00887868150616Affixus®8151124208151124202026-03-19
00887868150883Affixus®8151113208151113202026-03-19
00887868150890Affixus®8151113408151113402026-03-19
00887868150906Affixus®8151113608151113602026-03-19
00887868150913Affixus®8151113808151113802026-03-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00887868580710Identity® Shoulder SystemZimmer, Inc.PAO2024-09-09
04026575439751LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-07-12
04026575534746LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-07-11
04026575439546LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439553LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439560LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575439577LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533510LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533527LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533534LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533541LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533558LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533565LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533572LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533589LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533596LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533602LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533619LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533626LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533633LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533640LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-04-22
04026575533411LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533428LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533442LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533657LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533718LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533725LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533732LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533749LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22
04026575533756LINK Embrace Shoulder System Line ExtensionWALDEMAR LINK GmbH & Co. KGPAO2024-01-22