OIC Variable Angle Small Fragment Locking Plate System

FDA UDI

Class II (US FDA UDI)

by Orthopaedic Implant Company, The

Identity

Trade Name: OIC Variable Angle Small Fragment Locking Plate System FDA UDI
Generic Name: Bone fixation plate pliers FDA UDI
Device Name: BENDING PLIERS FDA UDI
Model / Reference: 01-SF15 FDA UDI
Description: BENDING PLIERS FDA UDI

Identifiers

Primary DI / UDI-DI: 10811998033515 FDA UDI
510(k) Number: K140357 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Bone fixation plate pliers 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

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

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Bone fixation plate pliers

OIC Variable Angle Small Fragment Locking Plate System by Orthopaedic Implant Company, The — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Bone fixation plate pliers.

PLIERS — KLS-Martin L.P. · Class I
LEVEL ONE — KLS-Martin L.P. · Class I
Ambler Surgical — Ambler Surgical, LLC · Class I
VARIAX — Stryker Corp. · Class I
Evos Mini — Smith & Nephew, Inc. · Class I
Surgical Instrument — Jeil Medical Corporation · Class I
LEVEL ONE — KLS-Martin L.P. · Class I
Bioplate® — Bioplate, Inc. · Class I

Cleared under the same submission

K140357 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

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Manufacturer

Manufacturer: Orthopaedic Implant Company, The

Sources (1)

FDA UDI 5150c8de-f523-4eee-bda3-9bb5fa37667d 35 fields · synced May 30, 2026