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: Orthopaedic bone wire FDA UDI
Device Name: 1.6MM X 85MM PROVISIONAL WIRE (5 PACK) FDA UDI
Model / Reference: PW160-085P FDA UDI
Description: 1.6MM X 85MM PROVISIONAL WIRE (5 PACK) FDA UDI

Identifiers

Primary DI / UDI-DI: 20811998035530 FDA UDI
510(k) Number: K140357 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Orthopaedic bone wire 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: Orthopaedic bone wire

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 Orthopaedic bone wire.

mahe medical GmbH — mahe medical gmbh · Class II
SALVATION™ — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
De Soutter Medical — De Soutter Medical, Ltd. · Class I
SMOOTH K-WIRE, DOUBLE END TROCAR POINT — Biomet Orthopedics, Inc. · Class II
mahe medical GmbH — mahe medical gmbh · Class II
THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc. · Class II
gSource — GSOURCE, LLC. · Class II
APTUS — Medartis Inc. · Class II

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 912ea2db-a58d-4f8a-ad62-b933c9aab82e 35 fields · synced Jun 7, 2026