X-Twist PEEK Suture Anchor

FDA UDI

Class II (US FDA UDI)

by Parcus Medical Llc

Identity

Trade Name: X-Twist PEEK Suture Anchor FDA UDI
Generic Name: Tendon/ligament bone anchor, non-bioabsorbable FDA UDI
Device Name: X-Twist PK 4.75mm, 2x1.6mm Tapes, Blk FDA UDI
Model / Reference: XT24703 FDA UDI
Description: X-Twist PK 4.75mm, 2x1.6mm Tapes, Blk FDA UDI

Identifiers

Primary DI / UDI-DI: 00816342025348 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

Yes

FDA UDI

MRI Safety

MR Safe FDA UDI

Category: Tendon/ligament bone anchor, non-bioabsorbable

X-Twist PEEK Suture Anchor by Parcus Medical Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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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

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: Parcus Medical Llc

Sources (1)

FDA UDI 7d11395b-acb1-4a50-b584-a91dcda3532f 33 fields · synced May 31, 2026