MiTi

FDA UDI

Class II (US FDA UDI)

by Parcus Medical Llc

Identity

Trade Name: MiTi FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: 2.5mm MiTi Suture Anchor w/ One #2 Suture with Needles FDA UDI
Model / Reference: 10429 FDA UDI
Description: 2.5mm MiTi Suture Anchor w/ One #2 Suture with Needles FDA UDI

Identifiers

Catalog Number: 10429 FDA UDI
Primary DI / UDI-DI: M685104290 FDA UDI
510(k) Number: K111000 FDA UDI
FDA Product Code: MBI FDA UDI
GMDN Term: Tendon/ligament bone 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

Dimensions & Sizes

Size: Outer Diameter — 2.5 Millimeter FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

MiTi by Parcus Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Tendon/ligament bone anchor, non-bioabsorbable.

Hi-Fi — Conmed Corporation · Class II
FLIPTIGHT LOOP — RIVERPOINT MEDICAL LLC · Class II
Ecobone — Bonegraft Biomaterials Co. · Class III
fX — Bonegraft Biomaterials Co. · Class III
GII PANACRYL — DePuy Mitek, Inc. · Class II
Power Button Adjustable Loop — RIVERPOINT MEDICAL LLC · Class II
SignaLoc Screw — SIGNATURE ORTHOPAEDICS PTY LTD · Class II
JuggerKnot Soft Anchors — Biomet Orthopedics, Inc. · Class II

Cleared under the same submission

K111000 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: Parcus Medical Llc

Sources (1)

FDA UDI adeee23a-9327-45ad-83d6-83989f5b8c69 37 fields · synced May 30, 2026