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K Number
K072525
Device Name
ZIPKNOT, MODEL 1017-3000
Manufacturer
MEDICINELODGE, INC.
Date Cleared
2007-10-05

(28 days)

Product Code
FZP
Regulation Number
878.4300
Type
Special
Panel
SU
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The MedicineLodge ZipKnot™ is indicated for use in approximation and/or ligation of soft tissues using USP #2 braided polyethylene surgical suture.

Device Description

Not Found

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the "MedicineLodge ZipKnot™ Suture Fixation Device." This letter does not contain information about acceptance criteria or a study proving the device meets acceptance criteria.

The information typically found in such a study, including sample sizes, ground truth establishment, expert qualifications, and performance metrics, is not present in this regulatory correspondence. The letter primarily confirms that the device has been reviewed and deemed "substantially equivalent" to legally marketed predicate devices, allowing it to be marketed.

Therefore, I cannot provide the requested table and details based on the given input.

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.