FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862579997
Brand
Equinoxe
Company
Exactech, Inc.
Model
301-18-06
Catalog number
301-18-06
Published
2020-09-13
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
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented
PHXShoulder Prosthesis, Reverse Configuration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HSDProsthesis, Shoulder, Hemi-, Humeral, Metallic UncementedOrthopedic2
KWSProsthesis, Shoulder, Semi-Constrained, Metal/Polymer CementedOrthopedic2
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer CementedOrthopedic2
PHXShoulder Prosthesis, Reverse ConfigurationOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K162726000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162726000Exactech® Equinoxe® Preserve StemExactech, Inc.2017-02-01PHX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862579997PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586257999710885862579997

GMDN Terms#

Term, Definition table
TermDefinition
Medullary canal orthopaedic reamer, rigidAn orthopaedic surgical instrument designed to open and enlarge the medullary canal (e.g., in the femur, tibia, ulnar) for the insertion of various devices during prosthesis implantation or fracture fixation procedures. It is typically designed as a long, cylindrical, rigid shaft with straight, spiralled, or contoured flutes that function as cutting surfaces; it may include a transverse milling (spotfacing) burr to level the end of the bone (e.g., post amputation). It is typically made of a high-grade stainless steel and is available in various sizes. It is intended for manual or powered rotation. This is a reusable device intended to be sterilized prior to use.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
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
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
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031886Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031893Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031909Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031916Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031923Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031930Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031947Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031954Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031961CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031978CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031985CSR Shoulder SystemCATALYST ORTHOSCIENCE INC.KWT2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596031992EA Convertible SystemCATALYST ORTHOSCIENCE INC.KWS2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032005Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-17
00811596032012Reverse Shoulder SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-17
05404028001288SurgiCase PlannerMaterialise NVKWS2026-07-16
05404028001288SurgiCase PlannerMaterialise NVPHX2026-07-16
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.HSD2026-07-14
00811596031695EA Convertible SystemCATALYST ORTHOSCIENCE INC.PHX2026-07-14