ExoToe

Primary DI
B605SZR001
Brand
ExoToe
Company
EXOTOE, LLC
Model
SZR001
Catalog number
SZR001
Device description
ExoToe Sizing Template 5.5mm, 6.5mm, 7.5mm
Published
2023-04-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
JDRStaple, Fixation, Bone

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JDRStaple, Fixation, BoneOrthopedic2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K172205000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K172205000ExoToe StapleExotoe, LLC2018-01-11JDR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B605SZR001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical implant template, reusableA device designed to determine the appropriate size and placement of a non-dental implant for a patient prior to or during implantation surgery. It is typically available as a graduated set or an individual plate (e.g., a translucent plastic sheet or a cut metal shape) with patterns/sizes corresponding to the size of the implant to be used to aid the surgeon in final selection of implant size, placement, and/or adaption. It is used for, e.g., total- or partial-joint prostheses, bone fracture fixation implants (plates, nails, including skull plate implants) or other types of surgical implants. This is a reusable device.

Sterilization Methods#

Method table
Method
Moist Heat or Steam Sterilization

Regulatory Flags#

DUNS number
081016089
Device count
1
DM exempt
true
Lot or batch
true
Manufacturing date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B605FCP001ExoToeFCP001FCP0012023-04-27
B605EX055ExoToeEX0552020-06-19
B605EX060ExoToeEX0602020-06-19
B605EX065ExoToeEX0652020-06-19
B605EX070ExoToeEX0702020-06-19
B605EX075ExoToeEX0752020-06-19
B065EX055ExoToeEX0552020-06-19
B065EX060ExoToeEX0602020-06-19
B065EX065ExoToeEX0652020-06-19
B065EX070ExoToeEX0702020-06-19
B065EX075ExoToeEX0752020-06-19

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