FDA.report

Equinoxe®

Primary DI
10885862631640
Company
Exactech, Inc.
Model
321-19-20
Catalog number
321-19-20
Device description
CSB Peripheral Screw Depth Checker
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
10885862631640PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
10885862631640PrimaryGS10

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 depth gauge, reusableA surgical instrument designed to measure the depth of a recess, usually to measure the depth of holes being drilled in bone so that the surgeon can determine the length of the bone screw to be used. It may take two forms: 1) a device with a moveable (sliding) centrepiece (a prong), the tip of which is inserted into the recess to read from a scale; 2) a circular disc with a central hole which is clipped to a drill bit so that the device slides up as the drill bit is advanced. This is a reusable device intended to be sterilized prior to use.

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Contacts

No records found.

Other Devices From This Company

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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

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