Equinoxe

Primary DI
10885862186751
Brand
Equinoxe
Company
Exactech, Inc.
Model
320-02-38
Catalog number
320-02-38
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
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K110708000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K110708000EQUINOXE REVERSE SHOULDER COMPRESSION SCREW / 38MM AND 42MM GLENOSPHERE / SUPERIOR AUGMENT GLENOID PLATE, 10 DEGREES...Exactech, Inc.2011-04-01PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862186751PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586218675110885862186751

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
Device Size Text, specify0
Outer Diameter38Millimeter

Regulatory Flags#

DUNS number
157565946
Device count
1
Serial number
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
10885862094780OpteCure650-00-01650-00-012016-07-17
10885862094797OpteCure650-00-02650-00-022016-07-17
10885862094803OpteCure650-00-05650-00-052016-06-17
10885862094810OpteCure650-00-10650-00-102016-07-17
10885862094827Optecure650-00-20650-00-202016-09-19
10885862094841OpteCure+CCC652-00-01652-00-012016-07-17
10885862094858OpteCure+CCC652-00-02652-00-022016-07-17
10885862094865OpteCure+CCC652-00-05652-00-052016-07-17
10885862094872OpteCure+CCC652-00-10652-00-102016-07-17
10885862094889OpteCure+CCC652-00-20652-00-202016-07-17
10885862095039Ossigen660-00-20660-00-202016-07-17
10885862252593Entice +CCC692-00-01692-00-012016-07-17
10885862252609Entice +CCC692-00-02692-00-022016-07-17
10885862252616Entice +CCC692-00-05692-00-052016-07-17
10885862252623Entice +CCC692-00-10692-00-102016-07-17
10885862252630Entice +CCC692-00-20692-00-202016-07-17
10885862252845Entice690-00-01690-00-012016-07-17
10885862252852Entice690-00-02690-00-022016-07-17
10885862252869Entice690-00-05690-00-052016-07-17
10885862252876Entice690-00-10690-00-102016-07-17

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07630542795602Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795817Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795824Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795831Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795848Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795855Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
07630542795879Anatomic Shoulder ProsthesisMedacta International SAKWS2026-09-28
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
00889024707047Signature ONE Software PackageOrthosoft IncKWS2026-07-10
00889024707047Signature ONE Software PackageOrthosoft IncKWT2026-07-10
00887868554391Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554391Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWS2024-02-09
00887868554407Signature™ Comprehensive®Orthosoft IncKWT2024-02-09
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-13
00885556810613AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-13
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810057AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810064AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810071AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810071AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810125AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810125AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810132AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08
00885556810132AETOS Shoulder SystemSmith & Nephew, Inc.KWT2023-02-08
00885556810149AETOS Shoulder SystemSmith & Nephew, Inc.KWS2023-02-08