MectaTap

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name: MectaTap FDA UDI
Generic Name: Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Device Name: MectaTap TI Ø6.5 FDA UDI
Model / Reference: 05.10.014 FDA UDI
Description: MectaTap TI Ø6.5 FDA UDI

Identifiers

Primary DI / UDI-DI: 07630040734233 FDA UDI
510(k) Number: K191677 FDA UDI
FDA Product Code: MBI 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
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

MectaTap by Medacta International — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

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

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Anchorsure — DESARROLLO E INVESTIGACION MEDICA ARAGONESA SL · Class II
FiberStitch™ Implant, Reverse Curve with two Polyester Implants and 2-0 FiberWir — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class II
Heli-FX™ Thoracic EndoAnchor™ System — MEDTRONIC VASCULAR, INC. · Class II
JUGGERSTITCH™ — Biomet Orthopedics, Inc. · Class II
JuggerStitch® — Biomet Orthopedics, Inc. · Class II
Heli-FX™ EndoAnchor™ System — MEDTRONIC, INC. · Class II
Lateral Suture Anchor, PEEK 6.5mm x 20mm — BIOPRO, INC. · Class II

Cleared under the same submission

K191677 also covers:

MectaTap — Medacta International

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 eb48db43-cefc-4847-b0c1-6ae721c21c20 34 fields · synced May 30, 2026