SnugFit All-Suture Anchor

FDA UDI

Class II (US FDA UDI)

by Medacta International

Identity

Trade Name: SnugFit All-Suture Anchor FDA UDI
Generic Name: Soft-tissue/mesh anchor, non-bioabsorbable FDA UDI
Device Name: SnugFit All-Suture anchor Size 2 – Short – 2x USP#2 / 1x Tape FDA UDI
Model / Reference: 05.11.026 FDA UDI
Description: SnugFit All-Suture anchor Size 2 – Short – 2x USP#2 / 1x Tape FDA UDI

Identifiers

Primary DI / UDI-DI: 07630345717184 FDA UDI
510(k) Number: K203485 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

MRI Safety

MR Safe FDA UDI

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

SnugFit All-Suture Anchor 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.

HNM MEDICAL — HNM STAINLESS, LLC. · Class II
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

K203485 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Medacta International

Sources (1)

FDA UDI 50bb9c23-4ff7-49d2-862f-0d0c20e552ff 34 fields · synced Jun 8, 2026