Grappler Interference Screw System

FDA UDI

Class I (US FDA UDI)

by Paragon 28

Identity

Trade Name: Grappler Interference Screw System FDA UDI
Generic Name: Cannulated surgical drill bit, reusable FDA UDI
Device Name: Ø4.0 Cannulated Drill w/ Depth Markings FDA UDI
Model / Reference: P41-910-4015 FDA UDI
Description: Ø4.0 Cannulated Drill w/ Depth Markings FDA UDI

Identifiers

Catalog Number: P41-910-4015 FDA UDI
Primary DI / UDI-DI: 00889795107138 FDA UDI
FDA Product Code: HTW FDA UDI
GMDN Term: Cannulated surgical drill bit, reusable FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Unsafe FDA UDI

Category: Cannulated surgical drill bit, reusable

Grappler Interference Screw System by Paragon 28 — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cannulated surgical drill bit, reusable.

Thunderbolt — RESPONSIVE ORTHOPEDICS LLC · Class I
4.0 x 125mm Drill Bit Cann AO — OsteoCentric Technologies,Inc · Class II
GIRO GROWTH MODULATION SYSTEM — Orthopediatrics Canada ULC · Class I
EBA2 — Citieffe · Class II
Summa Orthopaedics System Surgical Instrument — Jeil Medical Corporation · Class I
DynaNail — Medshape, Inc. · Class I
BIXCUT — Stryker Corp. · Class I
FREE GLIDING SCFE SCREW SYSTEM — Orthopediatrics Canada ULC · Class I

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 I	Pending data

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Manufacturer

Manufacturer: Paragon 28

Sources (1)

FDA UDI 9caea1f0-f3d2-4f18-8e0e-d0523209f6cc 34 fields · synced May 31, 2026