FDA.report

Equinoxe

Primary DI
10885862591388
Brand
Equinoxe
Company
Exactech, Inc.
Model
371-01-20
Catalog number
371-01-20
Device description
EQUINOXE PHX COMPRESSION SCREW DRILL GUIDE
Published
2024-03-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
FZXGuide, Surgical, Instrument
HRSPlate, fixation, bone

Product Code Classifications

CodeDeviceSpecialtyClass
FZXGuide, Surgical, InstrumentGeneral, Plastic Surgery1
HRSPlate, Fixation, BoneOrthopedic2

Premarket Submissions

SubmissionSupplement
K223933000

Premarket Details

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

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
10885862591388PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
157565946
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
10885862609588Vantage351-21-23351-21-232026-03-19
10885862639622AcuMatch103-00-01103-00-012026-03-19
10885862648037Equinoxe313-01-38313-01-382026-03-19
10885862648044Equinoxe313-01-41313-01-412026-03-19
10885862648051Equinoxe313-01-44313-01-442026-03-19
10885862648068Equinoxe313-01-47313-01-472026-03-19
10885862648075Equinoxe313-01-50313-01-502026-03-19
10885862648082Equinoxe313-01-53313-01-532026-03-19
10885862648099Equinoxe313-05-01313-05-012026-03-19
10885862648105Equinoxe313-05-02313-05-022026-03-19
10885862648129Equinoxe313-07-01313-07-012026-03-19
10885862648136Equinoxe313-07-02313-07-022026-03-19
10885862648143Equinoxe313-07-03313-07-032026-03-19
10885862648150Equinoxe313-07-05313-07-052026-03-19
10885862648167Equinoxe313-07-07313-07-072026-03-19
10885862648174Equinoxe313-07-10313-07-102026-03-19
10885862648259Equinoxe313-25-38313-25-382026-03-19
10885862648266Equinoxe313-25-41313-25-412026-03-19
10885862648273Equinoxe313-25-44313-25-442026-03-19
10885862648280Equinoxe313-25-47313-25-472026-03-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00888118143266PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143273PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143280PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143297PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143303PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143310PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143327PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143334PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143341PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143358PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143365PURE PECTUSKLS-Martin L.P.HRS2026-03-23
00888118143372PURE PECTUSKLS-Martin L.P.HRS2026-03-23
08800200200079Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
08800200200086Drain-TGJSR MEDICAL CO., LTD.FZX2026-03-23
00889024706965PSN 10MM M/L SHIFT BLOCKZimmer, Inc.FZX2026-03-19
10885862649690EquinoxeExactech, Inc.HRS2026-03-19
03662663143462MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143479MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143486MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143493MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143509MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143516MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143523MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
03662663143530MaxAn Anterior Cervical Plate SystemHighridge Medical, LLCFZX2026-03-17
00763000885212n/aMEDTRONIC SOFAMOR DANEK, INC.FZX2026-03-16
00840277133410Innomed, Inc.INNOMED, INC.FZX2026-03-11
00841506141466Distal Elbow Plating SystemSKELETAL DYNAMICS L.L.C.HRS2026-03-05
10705034578866N/AMedos International SàrlFZX2026-03-05
10705034578873N/AMedos International SàrlFZX2026-03-05
10705034578880N/AMedos International SàrlFZX2026-03-05