FDA.reportPublic FDA data

Comprehensive® VRS™

Primary DI
00880304834026
Brand
Comprehensive® VRS™
Company
Biomet Orthopedics, LLC
Model
110031378
Catalog number
110031378
Published
2016-09-24
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
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K152754000
K202232000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K152754000COMPREHENSIVE VAULT RECONSTRUCTION SYSTEM (VRS)Biomet Manufacturing Corp2016-05-16PHX
K202232000Comprehensive Vault Reconstruction SystemBiomet Manufacturing Corp2021-02-19PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304834026PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304834026008803048340268803048340260880304834026

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder prosthesis base plateA sterile component of a reverse shoulder prosthesis that consists of a metal plate [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] intended to be firmly attached to the scapula with screws. It is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)348-9500customerservice@zimmerbiomet.com

Regulatory Flags#

DUNS number
129278169
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
00880304474185Arcos® Modular Revision Hip System11-30210211-3021022015-10-24
00880304474246Arcos® Modular Revision Hip System11-30210111-3021012015-10-24
00880304539259Arcos® Modular Revision Hip System11-30210911-3021092015-10-24
00889024711280Jgrknt Reusable Fishmouth Perc GuideSSI008662SSI0086622026-08-25
00889024712034Percutaneous Soft Anchor Short 1.4mm GuideSSI008661SSI0086612026-08-25
00880304527386Active Articulation0100009900100009902020-05-15
00880304527393Active Articulation0100009910100009912020-05-15
00880304485020Active Articulation Hip SystemEP-200144EP-2001442015-11-03
00880304485037Active Articulation Hip SystemEP-200146EP-2001462015-11-03
00880304485044Active Articulation Hip SystemEP-200148EP-2001482015-10-24
00880304485051Active Articulation Hip SystemEP-200150EP-2001502015-10-24
00880304485068Active Articulation Hip SystemEP-200152EP-2001522015-10-24
00880304485075Active Articulation Hip SystemEP-200154EP-2001542015-10-24
00880304485082Active Articulation Hip SystemEP-200156EP-2001562015-10-24
00880304485099Active Articulation Hip SystemEP-200158EP-2001582015-10-24
00880304485105Active Articulation Hip SystemEP-200160EP-2001602015-10-24
00880304485112Active Articulation Hip SystemEP-200162EP-2001622015-10-24
00880304485129Active Articulation Hip SystemEP-200164EP-2001642015-11-04
00880304485136Active Articulation Hip SystemEP-200166EP-2001662015-10-24
00880304491328Active Articulation™ Dual Mobility Hip SystemXL-200144XL-2001442015-10-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00811596032524F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032531F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032548F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032555F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032562F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032579F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032586F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032593F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032609F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032616F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032623F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032630F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032647F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032654F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032661F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032678F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032685F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032982F1x Fracture Stem SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-25
00811596032036Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032050Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032067Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032074Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032081Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032098Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032104Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032111Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032128Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032135Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032142Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18
00811596032159Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-08-18