FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862538710
Brand
Equinoxe
Company
Exactech, Inc.
Model
319-00-30
Catalog number
319-00-30
Device description
STEMLESS SIZE GUIDE HANDLE
Published
2022-07-28
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
PKCProsthesis, total anatomic shoulder, uncemented metaphyseal humeral stem with no diaphyseal incursion, semi-constrained

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PKCProsthesis, Total Anatomic Shoulder, Uncemented Metaphyseal Humeral Stem With No Diaphyseal Incursion, Semi-ConstrainedOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K192097000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K192097000Exactech® Equinoxe® Stemless Humeral ComponentsExactech, Inc.2020-04-29PKC

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862538710PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586253871010885862538710

GMDN Terms#

Term, Definition table
TermDefinition
Surgical instrument handle, non-torque-limitingA hand-held manual surgical instrument designed to attach to the proximal end of a surgical instrument (e.g., a screwdriver shaft) to allow the surgeon to perform manipulations with the instrument, such as manual rotation of a bone screw or reamer; it does not include a torque-limiting function. The device is typically made of metal and/or synthetic material and may have a straight or T-shaped handle grip which may include additional features such as a ratchet mechanism to allow the surgeon to maintain a constant hold on the handle when providing rotation in one direction. 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
10885862657244Equinoxe330-36-00330-36-002026-07-07
10885862657251Equinoxe330-36-03330-36-032026-07-07
10885862657268Equinoxe330-36-10330-36-102026-07-07
10885862657275Equinoxe330-36-13330-36-132026-07-07
10885862657282Equinoxe330-38-00330-38-002026-07-07
10885862657299Equinoxe330-38-03330-38-032026-07-07
10885862657305Equinoxe330-38-10330-38-102026-07-07
10885862657312Equinoxe330-38-13330-38-132026-07-07
10885862657329Equinoxe330-40-00330-40-002026-07-07
10885862657336Equinoxe330-40-03330-40-032026-07-07
10885862657343Equinoxe330-40-10330-40-102026-07-07
10885862657350Equinoxe330-40-13330-40-132026-07-07
10885862657367Equinoxe330-42-00330-42-002026-07-07
10885862657374Equinoxe330-42-03330-42-032026-07-07
10885862657381Equinoxe330-42-10330-42-102026-07-07
10885862657398Equinoxe330-42-13330-42-132026-07-07
10885862657442Equinoxe330-46-00330-46-002026-07-07
10885862657459Equinoxe330-46-03330-46-032026-07-07
10885862657466Equinoxe330-46-10330-46-102026-07-07
10885862657473Equinoxe330-46-13330-46-132026-07-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03701037307007Humelock II Cementless Shoulder SystemFX SOLUTIONSPKC2026-06-25
03701037319109ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPKC2026-06-25
03701037319116ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPKC2026-06-25
03701037319123ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPKC2026-06-25
03701037319130ORTHOPEDIC MANUAL SURGICAL INSTRUMENTFX SOLUTIONSPKC2026-06-25
00885556915943AETOS Shoulder SystemSmith & Nephew, Inc.PKC2026-05-18
B1132G1HB300010Shoulder Innovations Humeral Stemless SystemShoulder Innovations, Inc.PKC2026-05-04
B1132G1HB300020Shoulder Innovations Humeral Stemless SystemShoulder Innovations, Inc.PKC2026-05-04
00885556910122AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910139AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910146AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556910153AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919354AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919361AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919378AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919392AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00885556919446AETOS Shoulder SystemSmith & Nephew, Inc.PKC2025-11-17
00887868580802IDENTITY HumeralZimmer, Inc.PKC2025-10-10
03701037320426EasyTech AnatomicalFX SOLUTIONSPKC2025-03-03
03701037321010FX V135FX SOLUTIONSPKC2025-02-20
03701037321027FX V135FX SOLUTIONSPKC2025-02-20
03701037321034FX V135FX SOLUTIONSPKC2025-02-20
03701037321041FX V135FX SOLUTIONSPKC2025-02-20
03701037321058FX V135FX SOLUTIONSPKC2025-02-20
03701037321065FX V135FX SOLUTIONSPKC2025-02-20
03701037321072FX V135FX SOLUTIONSPKC2025-02-20
03701037321089FX V135FX SOLUTIONSPKC2025-02-20
03701037321096FX V135FX SOLUTIONSPKC2025-02-20
03701037321102FX V135FX SOLUTIONSPKC2025-02-20
00889024678736OsseoFit™ Stemless ShoulderZimmer, Inc.PKC2024-12-18