FDA.report

Equinoxe®

Primary DI
10885862631633
Company
Exactech, Inc.
Model
321-19-15
Catalog number
321-19-15
Device description
Adjustable Angle Drill Guide
Published
2024-08-13
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
false

Related Records

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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
10885862631633PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
10885862631633PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
KWTProsthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2Orthopedic888.3650YEligible

Premarket Submissions

SubmissionSupplement
K233482000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K233482000Equinoxe® Central Screw Baseplate SystemExactech, Inc.2024-07-18PHX

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.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

No records found.

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