FDA 510(k) Search

Search Filters

Search Everything

510k Number

Type

Panel

Product Code

Subsequent Product Code

Applicant Name (Manufacturer)

Device Name

Device Description

Intended Use

Predicate Devices

Reference Devices

510k Summary Text (Full-text Search)

Decision

Decision Date From

Decision Date To

Third Party Reviewed

Expedited Review

Is SaMD

Contains AI/ML

Is IVD

Is Diagnostic

Is Therapeutic

is PCCP Authorized

Has PDF Data

Sort By

Sort Order

Search Results

Found 2 results

510(k) Data Aggregation

K Number

Device Name

Memodyn Staple

Manufacturer

AUSTIN & ASSOCIATES, INC./TELOS MEDICAL EQUIPMENT

Date Cleared

2017-02-01

(238 days)

Product Code

JDR

Regulation Number

888.3030

Why did this record match?

Applicant Name (Manufacturer) :

/TELOS MEDICAL EQUIPMENT

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Memodyn Staple is intended for use in bone fixation on osteotomies, arthrodesis and fractures of the foot, ankle and hand.

Device Description

Memodyn Staple is a nitinol alloy ASTM F2063-12 memory staple that comes in sizes ranging from 8mm to 20mm, and is used for bone fixation on osteotomies, arthrodesis and fractures of the small bones of the foot, ankle and hand.

Ask a Question

K Number

Device Name

MEMODYN STAPLE

Manufacturer

TELOS MEDICAL EQUIPMENT

Date Cleared

2001-06-13

(288 days)

Product Code

JDR

Regulation Number

888.3030

Why did this record match?

Applicant Name (Manufacturer) :

TELOS MEDICAL EQUIPMENT

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized

Intended Use

Device Description

Ask a Question

Page 1 of 1