MectaFix CL Fixation Button with Continuous Loop

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name: MectaFix CL Fixation Button with Continuous Loop FDA UDI
Generic Name: Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Device Name: MectaFix Continuous Loop 50 mm FDA UDI
Model / Reference: 05.05.0029 FDA UDI
Description: MectaFix Continuous Loop 50 mm FDA UDI

Identifiers

Primary DI / UDI-DI: 07630971238107 FDA UDI
510(k) Number: K193165 FDA UDI
FDA Product Code: MBI FDA UDI
JDR FDA UDI
HWC FDA UDI
GMDN Term: Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3040 FDA UDI
888.3030 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Category: Soft-tissue/mesh anchor, non-bioabsorbable

MectaFix CL Fixation Button with Continuous Loop by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Soft-tissue/mesh anchor, non-bioabsorbable.

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Lateral Suture Anchor, PEEK 6.5mm x 20mm — BIOPRO, INC. · Class II

Cleared under the same submission

K193165 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

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Manufacturer

Manufacturer: Medacta International

Sources (1)

FDA UDI 31ed5ca4-5cc5-49f7-b9dc-0aba23dfeb63 34 fields · synced May 30, 2026