FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862087041
Brand
Equinoxe
Company
Exactech, Inc.
Model
321-02-46
Catalog number
321-02-46
Device description
INSERTER CLAMP, GLENOSPHERE, 46mm, LEFT
Published
2022-08-25
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
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
10885862087041PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586208704110885862087041

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic implant inserter/extractor, reusableA hand-held manual surgical instrument designed to insert or extract an implantable orthopaedic device (e.g., a bone nail, spiral blade, or bone fixation plate) through application of a striking or screwing force. It is an instrument in a one-piece or modular configuration with a mechanism that will attach and/or lock to part of the implant, and a mechanism to apply the striking force (e.g., on a pad/flange) using a surgical hammer or a weight that can slide along a shaft, or a mechanism for twisting (screwing) (e.g., T-handle). This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Circumference46Millimeter
Device Size Text, specify0

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

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