FDA.reportPublic FDA data

Anatomical Shoulder™ Fracture

Primary DI
00889024275393
Brand
Anatomical Shoulder™ Fracture
Company
Zimmer GmbH
Model
01.04227.364
Device description
Humeral Head Fracture Ø36 left - slim
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
HSDPROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K142403000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142403000Anatomical Shoulder System/Anatomical Shoulder Domelock System/Anatomical Shoulder Fracture SystemZimmer GmbH2014-11-24KWS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024275393PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024275393008890242753938890242753930889024275393

GMDN Terms#

Term, Definition table
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#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0
Outer Diameter36Millimeter

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
00889024290273NCB®02.01362.10802.01362.1082015-10-16
00889024290280NCB®-PH02.01362.11602.01362.1162016-11-07
00889024290891NCB®02.02150.01402.02150.0142015-10-16
00889024290907NCB®02.02150.01602.02150.0162015-10-16
00889024290914NCB®02.02150.01802.02150.0182015-10-16
00889024290921NCB®02.02150.02002.02150.0202015-10-16
00889024290938NCB®02.02150.02202.02150.0222015-10-16
00889024290945NCB®02.02150.02402.02150.0242015-10-16
00889024290952NCB®02.02150.02602.02150.0262015-10-16
00889024290969NCB®02.02150.02802.02150.0282015-10-16
00889024290976NCB®02.02150.03002.02150.0302015-10-16
00889024290983NCB®02.02150.03202.02150.0322015-10-16
00889024290990NCB®02.02150.03402.02150.0342015-10-16
00889024291003NCB®02.02150.03602.02150.0362015-10-16
00889024291010NCB®02.02150.03802.02150.0382015-10-16
00889024291027NCB®02.02150.04002.02150.0402015-10-16
00889024291034NCB®02.02150.04202.02150.0422015-10-16
00889024291041NCB®02.02150.04402.02150.0442015-10-16
00889024291058NCB®02.02150.04602.02150.0462015-10-16
00889024291065NCB®02.02150.04802.02150.0482015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630345775320Shoulder SystemMedacta International SAPHX2026-09-28
07630345775375Shoulder SystemMedacta International SAPHX2026-09-28
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07630542727535Shoulder SystemMedacta International SAPHX2026-09-28
07630542727542Shoulder SystemMedacta International SAPHX2026-09-28
07630542727559Shoulder SystemMedacta International SAPHX2026-09-28
07630542795008Shoulder SystemMedacta International SAPHX2026-09-28
07630542795015Shoulder SystemMedacta International SAPHX2026-09-28
07630542795022Shoulder SystemMedacta International SAPHX2026-09-28
07630542795039Shoulder SystemMedacta International SAPHX2026-09-28
07630542795046Shoulder SystemMedacta International SAPHX2026-09-28
07630542795053Shoulder SystemMedacta International SAPHX2026-09-28
07630542795060Shoulder SystemMedacta International SAPHX2026-09-28
07630542795077Shoulder SystemMedacta International SAPHX2026-09-28
07630542795084Shoulder SystemMedacta International SAPHX2026-09-28
07630542795091Shoulder SystemMedacta International SAPHX2026-09-28
07630542795107Shoulder SystemMedacta International SAPHX2026-09-28
07630542795114Shoulder SystemMedacta International SAPHX2026-09-28
07630542795121Shoulder SystemMedacta International SAPHX2026-09-28
07630542795138Shoulder SystemMedacta International SAPHX2026-09-28
07630542795145Shoulder SystemMedacta International SAPHX2026-09-28
07630542795152Shoulder SystemMedacta International SAPHX2026-09-28
07630542795169Shoulder SystemMedacta International SAPHX2026-09-28
07630542795176Shoulder SystemMedacta International SAPHX2026-09-28
07630542795183Shoulder SystemMedacta International SAPHX2026-09-28
07630542795190Shoulder SystemMedacta International SAPHX2026-09-28
07630542795206Shoulder SystemMedacta International SAPHX2026-09-28
07630542795213Shoulder SystemMedacta International SAPHX2026-09-28
07630542795220Shoulder SystemMedacta International SAPHX2026-09-28
07630542795237Shoulder SystemMedacta International SAPHX2026-09-28