FDA.reportPublic FDA data

Comprehensive® Reverse Shoulder

Primary DI
00887868504563
Brand
Comprehensive® Reverse Shoulder
Company
Biomet Orthopedics, LLC
Model
405800
Catalog number
405800
Published
2021-08-21
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
FZXGuide, surgical, instrument
HWTTEMPLATE
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
HWTTemplateOrthopedic1
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K132239000
K193373000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132239000COMPREHENSIVE REVERSE SHOULDER SCREWSBiomet Manufacturing Corp2013-09-06PHX
K193373000Comprehensive® Reverse ShoulderBiomet, Inc.2020-04-15PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00887868504563PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00887868504563008878685045638878685045630887868504563

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic bone wireA wire intended for the fixation of bone fractures that may be implanted or used short-term (e.g., to hold a plate in the correct position during an intervention). It may be used: 1) as a cerclage wire to aid bone fixation; 2) in a loop or figure-of-eight configuration to reattach, e.g., the tip of the elbow (olecranon), tibial tubercle, or greater trochanter; 3) to augment bone screw/plate fixation; or 4) as a Kirschner wire or K-Wire to stiffen (arthrodese) a toe or finger. It is made of metal [e.g., stainless steel, cobalt-chrome (Co-Cr)], and may be malleable or rigid; some types include a nut designed to be attached to the wire to prevent wire migration. This is a single-use device.

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
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
06937278653598CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653604CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653611CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278653628CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654250CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654267CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654281CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654304CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654748CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654755CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654762CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654779CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654786CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654823CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654830CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654847CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654854CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654861CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654878CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654885CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654892CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654908CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654915CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654922CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654939CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654946CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654953CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654960CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654977CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22
06937278654984CurawayZhejiang CuraWay Medical Technology Co., Ltd.FZX2026-08-22