Overwatch

FDA UDI

Class I (US FDA UDI)

by Spinal Elements, Inc.

Identity

Trade Name: OVERWATCH FDA UDI
Generic Name: Orthopaedic bone wire FDA UDI
Device Name: 1.4MM X 500MM NITINOL K-WIRE THREADED TROCAR TIP FDA UDI
Model / Reference: 108-320-420 FDA UDI
Description: 1.4MM X 500MM NITINOL K-WIRE THREADED TROCAR TIP FDA UDI

Identifiers

Primary DI / UDI-DI: 00840606158176 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Orthopaedic bone wire FDA UDI

Classification

Device Class: Class I FDA UDI
Regulation Number: 888.4540 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

Yes

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

This Orthopedic bone wire is a crucial medical device used for orthopedic procedures. It is designed to provide fixation and stabilization of bones, particularly in cases where surgery is necessary.

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
OIC Variable Angle Small Fragment Locking Plate System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
THP™ Hip Fracture Plating System — Biomet Orthopedics, Inc. · Class II
gSource — GSOURCE, LLC. · Class II

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 I	Pending data

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

Manufacturer

Manufacturer: Spinal Elements, Inc.

Sources (1)

FDA UDI 4cff3ff7-91ab-47cd-b146-23b3e3691bf1 33 fields · synced Jul 13, 2026