Precision MIS Bunion System

FDA UDI

Class II (US FDA UDI)

by Paragon 28

Identity

Trade Name: Precision MIS Bunion System FDA UDI
Generic Name: Cannulated surgical drill bit, single-use FDA UDI
Device Name: Ø2.4mm Cannulated Drill for Ø3.0 Screw, Short FDA UDI
Model / Reference: P27-110-2412 FDA UDI
Description: Ø2.4mm Cannulated Drill for Ø3.0 Screw, Short FDA UDI

Identifiers

Catalog Number: P27-110-2412 FDA UDI
Primary DI / UDI-DI: 00889795132567 FDA UDI
510(k) Number: K190586 FDA UDI
K241262 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Cannulated surgical drill bit, single-use 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

FDA UDI

Single Use

Yes

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

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: Cannulated surgical drill bit, single-use

Precision MIS Bunion System by Paragon 28 — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Cannulated surgical drill bit, single-use.

MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Sierra™ — SeaSpine Orthopedics Corporation · Class II
VersiTomic Low Profile Ø11.0 mm — T.A.G MEDICAL PRODUCTS AGRICULTURAL COOPERATIVE ASSOCIATION · Class I
FOREFOOT SOLUTIONS™ — Newdeal Sas · Class I
Arthrex® — Arthrex, Inc. · Class I
Arthrex® — Arthrex, Inc. · Class I
MEDLINE — MEDLINE INDUSTRIES, INC. · Class I
Arthrex® — Arthrex, Inc. · Class I

Cleared under the same submission

K190586 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: Paragon 28

Sources (1)

FDA UDI 684843f7-ec47-46ad-8d9e-7f269e86deec 35 fields · synced May 29, 2026