FDA.reportPublic FDA data

Equinoxe

Primary DI
10885862591234
Brand
Equinoxe
Company
Exactech, Inc.
Model
371-01-24
Catalog number
371-01-24
Device description
EQUINOXE PHX THREADED DRILL GUIDE, 2.7MM
Published
2024-03-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Single use
true

Product Codes#

Code, Name table
CodeName
FZXGuide, Surgical, Instrument
HRSPlate, fixation, bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223933000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223933000Exactech Equinoxe PHx Fracture System; Exactech EPIC ScrewsExactech, Inc.2023-09-25HRS

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10885862591234PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1088586259123410885862591234

GMDN Terms#

Term, Definition table
TermDefinition
Surgical drill guide, reusableA manual surgical device designed to simultaneously place, angle, and guide a rotating surgical drill on hard tissue (e.g., bone); some types are also intended for guiding bone-coring instruments (e.g., keel punch). It is designed in a tubular form or with guiding holes and may have serrations at its distal end to enable firm placement on hard tissue surfaces (it is not bored into the tissue); it can have a handle or be held by another device (e.g., orthopaedic jig), and typically allows protection of the surrounding soft tissue during surgery. It is typically made of metal and may have graduations along its length; it is not custom-made for a specific patient. This is a reusable device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Outer Diameter2.7Millimeter

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
00842188132568Tools-AFSTrimed, INC.FZX2026-07-24
00888233028875Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028882Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233028899Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086110Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086127Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086134Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086141Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086158Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086165Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086172Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086189Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086196Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086202Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00888233086219Pectus Blu (TM)BIOMET MICROFIXATION, INCHRS2026-07-23
00841731153128ARTEMIS FUZEVILEX LLCFZX2026-07-22
00888118147226LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147233LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147240LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147257LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147264LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147271LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147714LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147721LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147738LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
00888118147745LEVEL ONE EXTREMITYKLS-Martin L.P.FZX2026-07-21
03700569621261Newclip InstrumentsNEWCLIP TECHNICSFZX2026-05-11
07613327649109T2, PANGEAStryker GmbHHRS2025-09-25
07613327649130T2, PANGEAStryker GmbHHRS2025-09-25
07613327649253T2, PANGEAStryker GmbHHRS2025-09-25