FDA.reportPublic FDA data

Anatomical Shoulder™ Glenoid

Primary DI
00889024285859
Brand
Anatomical Shoulder™ Glenoid
Company
Zimmer GmbH
Model
01.04214.370
Device description
A.S. Glenoid M cemented
Published
2017-07-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K990136000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K990136000ANATOMICA GLENOID COMPONENTSulzer Orthopedics, Inc.1999-03-01KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024285859PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024285859008890242858598890242858590889024285859

GMDN Terms#

Term, Definition table
TermDefinition
Shoulder glenoid fossa prosthesis, prefabricatedAn implantable, prefabricated component of a total shoulder prosthesis (glenoid component) designed to replace or repair the glenoid fossa; it is not a custom-made device. It is cup-like in shape and typically made of polyethylene (PE), but may be made of metal or a combination of PE and metal; it may include fixation devices (e.g., screws) for attachment to the scapula.

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@zimmer.com

Regulatory Flags#

DUNS number
488133448
Device count
1
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024289956NCB®02.00024.40102.00024.4012016-09-24
00889024289963NCB®02.00024.40202.00024.4022016-09-24
00889024289970NCB®-PP02.00024.41102.00024.4112016-09-24
00889024289987NCB®-PP02.00024.41202.00024.4122016-09-24
00889024289994NCB®-PP02.00024.41302.00024.4132016-09-24
00889024290006NCB®-PP02.00024.41402.00024.4142016-09-24
00889024292680NCB®02.02263.00902.02263.0092015-10-16
00889024292697NCB®02.02263.01202.02263.0122015-10-16
00889024292703NCB®02.02263.01502.02263.0152015-10-16
00889024292710NCB®02.02263.01802.02263.0182015-10-16
00889024292727NCB®02.02263.02102.02263.0212015-10-16
00889024292741NCB®02.02263.10902.02263.1092015-10-16
00889024292758NCB®02.02263.11202.02263.1122015-10-16
00889024292765NCB®02.02263.11502.02263.1152015-10-16
00889024292772NCB®02.02263.11802.02263.1182015-10-16
00889024292789NCB®02.02263.12102.02263.1212015-10-16
00889024292796NCB®02.02263.20102.02263.2012015-10-16
00889024292802NCB®02.02263.20202.02263.2022015-10-16
00889024292819NCB®02.02263.30102.02263.3012015-10-16
00889024292826NCB®02.02263.30202.02263.3022015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542795602Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795817Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795824Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795831Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795848Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795855Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795879Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
00811596033460CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033477CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033484CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSKWT2026-09-22
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-13
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-13
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810071AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810071AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810125AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810125AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810132AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810132AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810149AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08