FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862617224
Brand
Equinoxe
Company
Exactech, Inc.
Model
SPI-045183
Catalog number
SPI-045183
Device description
Torque Defining Screw Drive
Published
2022-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
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
10885862617224PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586261722410885862617224

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic instrument extractorA hand-held manual surgical instrument designed to extract another orthopaedic instrument (e.g., instrument sleeve/guide) from a patient’s body during an orthopaedic surgical procedure. It is a robust instrument intended to clamp to the device intended to be extracted during the procedure; it is not intended for device introduction/insertion and is not intended for extraction of an implant. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
157565946
Device count
1
Lot or batch
true
Sterilization required before use
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08033390121736SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121743SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121804SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121828SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121835SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121859SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121873SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121880SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121897SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121910SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390121958SMR TT Hybrid GlenoidLIMACORPORATE SPAPHX2024-07-27
08033390108065SMR STEMLESSLIMACORPORATE SPAPHX2022-03-17
08033390134392SMR ShoulderLIMACORPORATE SPAPHX2021-11-27
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