FDA.reportPublic FDA data

COMPREHENSIVE SHOULDER

Primary DI
00880304568143
Brand
COMPREHENSIVE SHOULDER
Company
Biomet Orthopedics, LLC
Model
110005287
Catalog number
110005287
Published
2016-10-28
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KWSPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
KWTPROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED
MBFPROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER, UNCEMENTED
PAOprosthesis, shoulder, semi-constrained, metal/polymer + additive, cemented
PHXshoulder prosthesis, reverse configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
MBFProsthesis, Shoulder, Semi-Constrained, Metal/Polymer, UncementedOrthopedic2
PAOProsthesis, Shoulder, Semi-Constrained, Metal/Polymer + Additive, CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K130390000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K130390000COMPREHENSIVE CONVERTIBLE GLENOIDBiomet Manufacturing, Inc.2013-10-09PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00880304568143PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00880304568143008803045681438803045681430880304568143

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA hand-held tubular surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone), and to protect the surrounding soft tissue while the drill is in operation. It may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle at its proximal end for holding and manipulation, or it may be held by another device (e.g., orthopaedic jig). The device is typically dedicated to drill bit size, made of metal, and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes#

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

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

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
Sterilization required before use
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
00811596033460CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033477CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
00811596033484CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSKWT2026-09-22
03701037320440FX V135 Shoulder ProsthesisFX SOLUTIONSPHX2026-09-22
03701037321188ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPHX2026-09-22
00840097533919Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533926Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533933Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533940Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533957Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533964Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533971Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533988Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097533995Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534008Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534015Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
00840097534022Veritas HemiarthroplastyRestor3d, Inc.PHX2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI200100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI206000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI208000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI208000Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI220050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18
B1132N2GI220050Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI220100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWS2026-09-18
B1132N2GI220100Shoulder Innovations InSet GOShoulder Innovations, Inc.KWT2026-09-18