FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862181039
Brand
Equinoxe
Company
Exactech, Inc.
Model
341-01-28
Catalog number
341-01-28
Device description
DRILL BIT, FRACTURE PLATE, 2.8mm
Published
2022-08-18
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
10885862181039PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586218103910885862181039

GMDN Terms#

Term, Definition table
TermDefinition
Fluted surgical drill bit, reusableA shaft of metal with an obtuse, V-shaped cutting edge designed to be rotated to bore into bone to create a hole of the same dimension as the diameter of the shaft. This device, commonly called a "twist drill", has a cylindrical design with a double-edged cutting head that is formed from two spiralled flutes that extend the length of the insertion part of the drill. At the proximal end, it is usually inserted into a surgical power tool or a surgical hand drill/brace. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.8Millimeter

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

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