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 pin, non-bioabsorbable FDA UDI
Device Name: 1.6MM X 85MM PROVISIONAL WIRE (SINGLE UNIT) FDA UDI
Model / Reference: PW160-085 FDA UDI
Description: 1.6MM X 85MM PROVISIONAL WIRE (SINGLE UNIT) FDA UDI

Identifiers

Primary DI / UDI-DI: 10811998035533 FDA UDI
510(k) Number: K140357 FDA UDI
FDA Product Code: HWC FDA UDI
GMDN Term: Orthopaedic bone pin, non-bioabsorbable 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

Yes

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

Dimensions & Sizes

Size: Outer Diameter — 1.6 Millimeter FDA UDI
Length — 85 Millimeter FDA UDI

Category: Orthopaedic bone pin, non-bioabsorbable

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 pin, non-bioabsorbable.

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KW03-310-18.A — newbox medical GmbH · Class IIb
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IlluminOss — ILLUMINOSS MEDICAL INC. · Class II
XtraFix® External Fixation System — Zimmer, Inc. · Class II
CALIBRATED GUIDE WIRE, THREADED TROCAR POINT — Biomet Orthopedics, Inc. · Class II
TRAUMA FIXATION SYSTEMS — Biomet Orthopedics, Inc. · Class II
SMART TSF — Smith & Nephew, 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

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Manufacturer

Manufacturer: Orthopaedic Implant Company, The

Sources (1)

FDA UDI cfa5b7af-1447-473b-bb93-c505cdab2bb2 36 fields · synced May 30, 2026