Synd EZ

FDA UDI

Class II (US FDA UDI)

by Parcus Medical Llc

Identity

Trade Name: Synd EZ FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: Synd-EZ Solo Ti FDA UDI
Model / Reference: 11225 FDA UDI
Description: Synd-EZ Solo Ti FDA UDI

Identifiers

Primary DI / UDI-DI: 00816342025003 FDA UDI
510(k) Number: K191783 FDA UDI
K202259 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

MRI Safety

MR Conditional FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

Synd EZ 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

K191783 also covers:

Synd-EZ — PARCUS MEDICAL LLC
Synd-EZ — PARCUS MEDICAL LLC

K202259 also covers:

Actiflip — PARCUS MEDICAL LLC

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 78e823bd-6f16-446c-8a3a-139b926e0adc 34 fields · synced May 30, 2026