FDA.report

Anatomical Shoulder™

Primary DI
00889024480100
Brand
Anatomical Shoulder™
Company
Zimmer GmbH
Model
01.04227.408
Catalog number
01.04227.408
Published
2017-07-28
Public version status
Update
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
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED

Product Code Classifications

CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00889024480100PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024480100008890244801008890244801000889024480100

GMDN Terms

TermDefinition
Total shoulder prosthesisA sterile implantable artificial substitute for a shoulder joint designed to replace both articulating surfaces of the damaged (e.g., fractured) and/or degenerative (e.g., arthritic) joint. It includes glenoid and humeral (head and stem) components typically with parts made of metal and polyethylene (PE). Fixation devices for implantation (e.g., screws) may be included and implantation may be performed with or without bone cement.

Device Sizes

TypeValueUnit
Device Size Text, specify0
Device Size Text, specify0

Sterilization Methods

Method

Contacts

PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags

DUNS number
488133448
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
false
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
00889024292512NCB®02.02261.0132024-05-03
00889024292550NCB®02.02261.1132024-05-03
00889024296558NCB®02.03156.0902024-05-03
00889024296565NCB®02.03156.0952024-05-03
00889024296572NCB®02.03156.1002024-05-03
00889024593152Wagner Cone Prosthesis®01.00561.31301.00561.3132022-12-13
00889024593176Wagner Cone Prosthesis®01.00561.21501.00561.2152022-12-13
00889024593183Wagner Cone Prosthesis®01.00561.21601.00561.2162022-12-13
00889024593190Wagner Cone Prosthesis®01.00561.21701.00561.2172022-12-13
00889024593206Wagner Cone Prosthesis®01.00561.31401.00561.3142022-12-13
00889024593213Wagner Cone Prosthesis®01.00561.21801.00561.2182022-12-13
00889024593237Wagner Cone Prosthesis®01.00561.21901.00561.2192022-12-13
00889024593251Wagner Cone Prosthesis®01.00561.31701.00561.3172022-12-13
00889024593268Wagner Cone Prosthesis®01.00561.31801.00561.3182022-12-13
00889024593534Wagner SL Revision®01.00102.62401.00102.6242022-12-13
00889024593541Wagner SL Revision®01.00102.62501.00102.6252022-12-13
00889024593145Wagner Cone Prosthesis®01.00561.21301.00561.2132022-12-13
00889024593169Wagner Cone Prosthesis®01.00561.21401.00561.2142022-12-13
00889024593220Wagner Cone Prosthesis®01.00561.31501.00561.3152022-12-13
00889024593244Wagner Cone Prosthesis®01.00561.31601.00561.3162022-12-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
10885862648099EquinoxeExactech, Inc.HSD2026-03-19
10885862648105EquinoxeExactech, Inc.HSD2026-03-19
10885862648129EquinoxeExactech, Inc.HSD2026-03-19
10885862648136EquinoxeExactech, Inc.HSD2026-03-19
10885862648167EquinoxeExactech, Inc.HSD2026-03-19
10885862648174EquinoxeExactech, Inc.HSD2026-03-19
10885862648259EquinoxeExactech, Inc.HSD2026-03-19
10885862648266EquinoxeExactech, Inc.HSD2026-03-19
10885862648273EquinoxeExactech, Inc.HSD2026-03-19
10885862648280EquinoxeExactech, Inc.HSD2026-03-19
10885862648297EquinoxeExactech, Inc.HSD2026-03-19
10885862648303EquinoxeExactech, Inc.HSD2026-03-19
10885862662446EquinoxeExactech, Inc.HSD2026-03-19
10885862662453EquinoxeExactech, Inc.HSD2026-03-19
10885862662460EquinoxeExactech, Inc.HSD2026-03-19
10885862662477EquinoxeExactech, Inc.HSD2026-03-19
10885862662484EquinoxeExactech, Inc.HSD2026-03-19
10885862662491EquinoxeExactech, Inc.HSD2026-03-19
10885862665782EquinoxeExactech, Inc.HSD2026-03-19
03661489523618JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723421JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723438JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723445JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723452JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723469JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723476JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723483JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723490JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723506JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16
03661489723537JARVIS Diaphyseal Stem StandardFOURNITURES HOSPITALIERES INDUSTRIEHSD2025-12-16