FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862086396
Brand
Equinoxe
Company
Exactech, Inc.
Model
320-01-42
Catalog number
320-01-42
Published
2015-10-30
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

Product Codes#

Code, Name table
CodeName
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K063569000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K063569000EQUINOXE REVERSE SHOULDER SYSTEMExactech, Inc.2007-02-23PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862086396PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586208639610885862086396

GMDN Terms#

Term, Definition table
TermDefinition
Reverse shoulder prosthesis headA sterile component of a reverse shoulder prosthesis that consists of a hemisphere-shaped metal or combined metal/polyethylene piece (glenosphere) intended to be attached to the reverse shoulder base plate, or directly to the glenoid fossa of the scapula, to articulate with the reverse shoulder cup.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter42Millimeter

Regulatory Flags#

DUNS number
157565946
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
10885862660527AcuMatch103-61-00103-61-002026-05-28
10885862660541AcuMatch103-61-07103-61-072026-05-28
10885862660558AcuMatch103-61-10103-61-102026-05-28
10885862660565AcuMatch103-61-97103-61-972026-05-28
10885862663207N/A101-14-00101-14-002026-05-28
10885862656117Newton02-521-90-200402-521-90-20042026-05-27
10885862656124Newton02-521-90-200502-521-90-20052026-05-27
10885862656131Newton02-521-90-200602-521-90-20062026-05-27
10885862656148Newton02-521-90-200702-521-90-20072026-05-27
10885862656155Newton02-521-90-200802-521-90-20082026-05-27
10885862656162Newton02-521-90-200902-521-90-20092026-05-27
10885862656179Newton02-521-90-201002-521-90-20102026-05-27
10885862653697Alteon190-00-01190-00-012026-05-26
10885862653703Alteon190-00-02190-00-022026-05-26
10885862653710Alteon190-00-03190-00-032026-05-26
10885862653727Alteon190-00-04190-00-042026-05-26
10885862653734Alteon190-00-05190-00-052026-05-26
10885862653741Alteon190-00-06190-00-062026-05-26
10885862653758Alteon190-00-07190-00-072026-05-26
10885862653765Alteon190-00-08190-00-082026-05-26

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
B1132A2HI000100Shoulder Innovations InSet 95 Humeral StemShoulder Innovations, Inc.KWT2026-05-28
08033390108065SMR STEMLESSLIMACORPORATE SPAKWT2022-03-17
08033390106757BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106764BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106771BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106788BONE SCREWSLIMACORPORATE SPAKWT2020-11-27
08033390106795BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106801BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106818BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106825BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106849BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106856BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106863BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106870BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106887BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106894BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106900BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106917BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106924BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390106931BONE SCREWSLIMACORPORATE SPAKWT2019-11-28
08033390038935SMR Shoulder system LIMACORPORATE SPAKWT2018-09-21
08033390085984SMR Shoulder LIMACORPORATE SPAKWT2017-07-05
08033390087834SMR Shoulder LIMACORPORATE SPAKWT2017-07-05
08033390105866SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106412SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106429SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106436SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390106443SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390108768SMR ShoulderLIMACORPORATE SPAKWT2017-02-25
08033390108775SMR ShoulderLIMACORPORATE SPAKWT2017-02-25