FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862230935
Brand
Equinoxe
Company
Exactech, Inc.
Model
341-02-30
Catalog number
341-02-30
Device description
FX PLATE SCREW GUIDE RIGHT
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
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K093978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K093978000EXACTECH EQUINOXE PROXIMAL HUMERUS FRACTURE PLATE SYSTEMExactech, Inc.2010-05-11HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862230935PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586223093510885862230935

GMDN Terms#

Term, Definition table
TermDefinition
Orthopaedic fixation implant alignment toolA surgical instrument designed to facilitate the correct orientation (alignment) of an orthopaedic fixation implant, implants, or system of implants during orthopaedic surgery. It may be used, e.g., to align a series of bone screws in an implant system for posterior stabilization of the spine, or to align a spinal anatomical fixation implant. It is available in a variety of shapes and sizes and allows the surgeon to engage this device with the implant(s) and align them in the desired configuration. It is typically made of high-grade stainless steel or titanium alloy and will have profiled features to fit into the implant(s) to align them. 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
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00810112592993TriLeap Lower Extremity Anatomic Plating SystemSynthes GmbHHRS2024-02-22
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