FDA.reportPublic FDA data

ExoToe

Primary DI
B605FCP001
Brand
ExoToe
Company
EXOTOE, LLC
Model
FCP001
Catalog number
FCP001
Device description
ExoToe Crimping Forceps
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
B605FCP001PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Surgical soft-tissue manipulation forceps, scissors-like, reusableA hand-held, manual, open-surgery instrument designed to grasp, manipulate, dissect, and/or clamp soft-tissues (e.g., organs, blood vessels); it is not intended for grasping/clamping bone or teeth, nor is it dedicated to ophthalmic surgery and is not a dedicated biopsy device. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.

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
B605SZR001ExoToeSZR001SZR0012023-04-27
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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Primary DI, Brand, Company table
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10886705001033LUPINEDEPUY MITEK, LLCJDR2025-03-04
10886705001040LUPINEDEPUY MITEK, LLCJDR2025-03-04
00810111223683SpeedPlate - SpeedAkinTreace Medical Concepts, Inc.JDR2025-01-27
00810111223485TMC SpeedMTPTreace Medical Concepts, Inc.JDR2024-11-18
07630037889397APTUSMedartis AGJDR2023-03-03
10888867042633Arthrex®ARTHREX, INC.JDR2021-12-03
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10888867042695Arthrex®ARTHREX, INC.JDR2021-12-03
00811714035345Thunderbolt Suture AssemblyRESPONSIVE ORTHOPEDICS LLCJDR2021-04-29
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07630971238039MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238046MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238053MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
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07630971238077MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238084MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238091MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
07630971238107MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
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07630971238121MectaFix CL Fixation Button with Continuous LoopMedacta International SAJDR2020-06-12
00815432025138MotoBANDCROSSROADS EXTREMITY SYSTEMSJDR2018-08-06