FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862286871
Brand
Equinoxe
Company
Exactech, Inc.
Model
320-02-46
Catalog number
320-02-46
Published
2015-11-16
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
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K150458000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K150458000Exactech Equinoxe Reverse Shoulder 46x21mm GlenosphereExactech, Inc.2015-05-14PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862286871PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586228687110885862286871

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 Diameter46Millimeter

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
00840097503677Veritas InstrumentationRestor3d, Inc.PHX2026-10-16
07630699705950Shoulder SystemMedacta International SAPHX2026-10-01
07630699705967Shoulder SystemMedacta International SAPHX2026-10-01
07630699705974Shoulder SystemMedacta International SAPHX2026-10-01
07630699705998Shoulder SystemMedacta International SAPHX2026-10-01
07630699706001Shoulder SystemMedacta International SAPHX2026-10-01
07630699706018Shoulder SystemMedacta International SAPHX2026-10-01
07630699706032Shoulder SystemMedacta International SAPHX2026-10-01
07630699706049Shoulder SystemMedacta International SAPHX2026-10-01
07630699706056Shoulder SystemMedacta International SAPHX2026-10-01
B1132R2HC300100Shoulder Innovations RSA Glenosphere Trial Instrument CaseShoulder Innovations, Inc.PHX2026-09-30
07630345775320Shoulder SystemMedacta International SAPHX2026-09-28
07630345775375Shoulder SystemMedacta International SAPHX2026-09-28
07630542727528Shoulder SystemMedacta International SAPHX2026-09-28
07630542727535Shoulder SystemMedacta International SAPHX2026-09-28
07630542727542Shoulder SystemMedacta International SAPHX2026-09-28
07630542727559Shoulder SystemMedacta International SAPHX2026-09-28
07630542795008Shoulder SystemMedacta International SAPHX2026-09-28
07630542795015Shoulder SystemMedacta International SAPHX2026-09-28
07630542795022Shoulder SystemMedacta International SAPHX2026-09-28
07630542795039Shoulder SystemMedacta International SAPHX2026-09-28
07630542795046Shoulder SystemMedacta International SAPHX2026-09-28
07630542795053Shoulder SystemMedacta International SAPHX2026-09-28
07630542795060Shoulder SystemMedacta International SAPHX2026-09-28
07630542795077Shoulder SystemMedacta International SAPHX2026-09-28
07630542795084Shoulder SystemMedacta International SAPHX2026-09-28
07630542795091Shoulder SystemMedacta International SAPHX2026-09-28
07630542795107Shoulder SystemMedacta International SAPHX2026-09-28
07630542795114Shoulder SystemMedacta International SAPHX2026-09-28
07630542795121Shoulder SystemMedacta International SAPHX2026-09-28