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: Manual orthopaedic bender, reusable FDA UDI
Device Name: UNIVERSAL PLATE BENDER FDA UDI
Model / Reference: 01-SF18 FDA UDI
Description: UNIVERSAL PLATE BENDER FDA UDI

Identifiers

Primary DI / UDI-DI: 10811998035489 FDA UDI
510(k) Number: K140357 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Manual orthopaedic bender, reusable 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: Manual orthopaedic bender, reusable

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 Manual orthopaedic bender, reusable.

MESA Small Stature Spinal System — K2M, INC. · Class I
Invictus — ALPHATEC SPINE, INC. · Class I
Kestrel® — Innovasis, Inc. · Class II
Surgical Instrument — OSTEONIC CO., Ltd. · Class I
Invictus — ALPHATEC SPINE, INC. · Class I
Dark Star Deformity — Republic Spine, LLC · Class II
g Source — GSOURCE, LLC. · Class I
CLAW CHARLOTTE — WRIGHT MEDICAL TECHNOLOGY, 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Orthopaedic Implant Company, The

Sources (1)

FDA UDI dd01c8fc-2455-4237-bc65-517234faf319 35 fields · synced May 30, 2026