FDA.report

Identity® Shoulder System

Primary DI
00887868580697
Brand
Identity® Shoulder System
Company
Zimmer, Inc.
Model
110047327
Catalog number
110047327
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

Related Records

Contact Domains

Product Codes

CodeName
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED

Product Code Classifications

CodeDeviceSpecialtyClass
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2

Premarket Submissions

SubmissionSupplement
K240876000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240876000Identity Shoulder SystemZimmer, Inc.2024-06-12MBF

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00887868580697PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868580697008878685806978878685806970887868580697

GMDN Terms

TermDefinition
Reverse shoulder prosthesis bodyA sterile component of a reverse shoulder prosthesis that consists of a metallic piece [e.g., cobalt-chrome-molybdenum (Co-Cr-Mo)], which may be coated [e.g., with hydroxyapatite (HA)], intended to form a connection between a humeral stem prosthesis and a reverse shoulder prosthesis cup.

Device Sizes

TypeValueUnit
Device Size Text, specify0

Sterilization Methods

Method

Contacts

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 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 DIBrandCompanyProduct codePublished
00889024706071Identity Inlay Small Tooth ReamerZimmer, Inc.MBF2026-02-23
00889024703759Versa-Dial® Shoulder SystemBiomet Orthopedics, LLCMBF2025-12-02
00889024691551Identity HumeralZimmer, Inc.MBF2025-09-22
00889024691582Identity HumeralZimmer, Inc.MBF2025-09-22
B1130S1GK000030Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
B1132L2HG700380Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
B1132L2HS700040Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
B1132L2HS700050Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-09-18
00889024691506Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691513Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691520Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691643Identity HumeralZimmer, Inc.MBF2025-09-17
00889024691650Identity HumeralZimmer, Inc.MBF2025-09-17
B1132L2HC000040Shoulder Innovations Inset Reverse Total ShoulderShoulder Innovations, Inc.MBF2025-09-13
B1132L1S0400000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S0600000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S0800000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S1000000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S1200000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L1S1400000Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L2HI000040Shoulder Innovations InSet 70 Humeral StemShoulder Innovations, Inc.MBF2025-05-29
B1132L2HI000110Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2025-05-12
B1132N1HS000400Shoulder Innovations TSAShoulder Innovations, Inc.MBF2025-04-18
B1132N1HS000460Shoulder Innovations TSAShoulder Innovations, Inc.MBF2025-04-18
B1132N1HS000520Shoulder Innovations TSAShoulder Innovations, Inc.MBF2025-04-18
B1132R2HC000050Shoulder Innovations IM Cut GuideShoulder Innovations, Inc.MBF2025-04-18
B1132R2HC000080Shoulder Innovations IM Cut GuideShoulder Innovations, Inc.MBF2025-04-18
B1132R2HC000090Shoulder Innovations IM Cut GuideShoulder Innovations, Inc.MBF2025-04-18
B1132L2HC000010Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2024-09-01
B1132L2HS000060Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.MBF2024-09-01