FDA.reportPublic FDA data

Trabecular Metal® Vivacit-E®

Primary DI
00889024269484
Brand
Trabecular Metal® Vivacit-E®
Company
Zimmer, Inc.
Model
00-4350-066-00
Catalog number
00-4350-066-00
Published
2017-09-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Conditional
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
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented

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
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K133378000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K133378000ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEMZimmer, Inc.2014-05-12PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00889024269484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00889024269484008890242694848890242694840889024269484

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

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-2759zimmer.consumerrelations@zimmerbiomet.com

Regulatory Flags#

DUNS number
056038268
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00889024081024XtraFix® Large External Fixation System00-5207-024-3000-5207-024-302016-08-09
00889024081055XtraFix® Large External Fixation System00-5207-032-3000-5207-032-302016-07-27
00889024081062XtraFix® Large External Fixation System00-5207-040-1000-5207-040-102016-07-28
00889024081079XtraFix® Large External Fixation System00-5207-040-7000-5207-040-702016-07-28
00889024081086XtraFix® Large External Fixation System00-5207-045-1000-5207-045-102016-07-28
00889024081093XtraFix® Large External Fixation System00-5210-009-0100-5210-009-012016-09-28
00889024081109XtraFix® Large External Fixation System00-5210-009-0200-5210-009-022016-09-28
00889024081147XtraFix® Large External Fixation System00-5210-019-0100-5210-019-012016-09-28
00889024081154XtraFix® Large External Fixation System00-5210-029-0100-5210-029-012016-09-28
00889024081178XtraFix® Large External Fixation System00-5210-040-0000-5210-040-002016-09-28
00889024081185XtraFix® Large External Fixation System00-5210-040-0100-5210-040-012016-09-28
00889024081192XtraFix® Large External Fixation System00-5210-040-0200-5210-040-022016-09-28
00889024081208XtraFix® Large External Fixation System00-5210-040-0300-5210-040-032016-09-28
00889024081215XtraFix® Large External Fixation System00-5210-040-0400-5210-040-042016-09-28
00889024081239XtraFix® Large External Fixation System00-5210-040-0600-5210-040-062016-09-28
00889024081253XtraFix® Large External Fixation System00-5210-050-0100-5210-050-012016-09-28
00889024081260XtraFix® Large External Fixation System00-5210-050-0200-5210-050-022016-09-28
00889024081277XtraFix® Large External Fixation System00-5210-050-0300-5210-050-032016-09-28
00889024081284XtraFix® Large External Fixation System00-5210-050-0400-5210-050-042016-09-28
00889024081307XtraFix® Large External Fixation System00-5210-050-0600-5210-050-062016-09-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWT2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.HSD2026-05-28
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWS2026-05-28
07613327668889Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668902Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668919Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327668896Modular ElbowHowmedica Osteonics Corp.HSD2025-02-24
07613327603361REUNIONStryker GmbHHSD2024-10-01
07613327603361REUNIONStryker GmbHKWS2024-10-01
07613327354331REUNIONStryker GmbHKWS2022-11-15
07613327354355REUNIONStryker GmbHKWS2022-11-15
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07613327354805REUNIONStryker GmbHKWS2022-11-15
07613327354843REUNIONStryker GmbHHSD2022-11-15
07613327354850REUNIONStryker GmbHHSD2022-11-15
07613327354867REUNIONStryker GmbHHSD2022-11-15
07613327354874REUNIONStryker GmbHHSD2022-11-15
07613327354898REUNIONStryker GmbHHSD2022-11-15
07613327354904REUNIONStryker GmbHKWS2022-11-15
07613327354935REUNIONStryker GmbHKWS2022-11-15
07613327354942REUNIONStryker GmbHKWS2022-11-15
07613327354980REUNIONStryker GmbHHSD2022-11-15
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