FDA.report

Equinoxe®

Primary DI
10885862625632
Company
Exactech, Inc.
Model
320-55-03
Catalog number
320-55-03
Device description
Central Screw Baseplate
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
true
Single use
true

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
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Identifiers

IdentifierTypeAgencyPackage quantityStatus
10885862625632PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
10885862625632PrimaryGS10

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
Reverse shoulder prosthesis base plateA sterile component of a reverse shoulder prosthesis that consists of a metal plate [e.g., titanium (Ti), cobalt-chrome (Co-Cr), stainless steel] intended to be firmly attached to the scapula with screws. It is intended to serve as the foundation for the reverse shoulder prosthesis head (glenosphere).

Device Sizes

TypeValueText
Angle8 degree
Device Size Text, specify0Left
Device Size Text, specify0Posterior Augment

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

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