FDA.reportPublic FDA data

Anatomical Shoulder™ Glenoid

Primary DI
00889024285873
Brand
Anatomical Shoulder™ Glenoid
Company
Zimmer GmbH
Model
01.04214.400
Device description
A.S. Glenoid L 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
00889024285873PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024285873008890242858738890242858730889024285873

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
00887868453120Avenir®01.08000.01201.08000.0122021-02-25
00889024298521Natural Nail®47-2487-002-0047-2487-002-002015-10-21
00889024298538Natural Nail®47-2487-002-0547-2487-002-052015-10-21
00889024298545Natural Nail®47-2487-002-1047-2487-002-102015-10-21
00889024298552Natural Nail®47-2487-002-1547-2487-002-152015-10-21
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
00889024506503Affixus® Natural Nail®1100356641100356642019-03-21
00889024506510Affixus® Natural Nail®1100372371100372372019-03-21
00889024506527Affixus® Natural Nail®1100356651100356652019-03-21
00889024506534Affixus® Natural Nail®1100356661100356662019-03-21
00889024506558Affixus® Natural Nail®1100356681100356682019-03-21
00889024277038Dynesys® Top-Loading System01.03956.4502015-10-16
00889024283688Dynesys®01.03710.0062015-10-16
00889024283695Dynesys®01.03710.6452016-03-14
00889024283701Dynesys®01.03711.1002016-03-14
00889024283718Dynesys®01.03711.2002016-03-14

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811596031961CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031978CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031985CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-17
05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031701EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031718EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031725EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031732EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031749EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-14
00811596031657EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031664EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031671EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00811596031688EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-13
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
03701037315897ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315903ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315910ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315927ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315934ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315941ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315958ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315965ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315972ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315989ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037315996ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037316009ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26
03701037316535ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSKWT2026-06-26