Surgical Instrument

FDA UDI

Class I (US FDA UDI)

by OSTEONIC CO., Ltd.

Identity

Trade Name: Surgical Instrument FDA UDI
Generic Name: Surgical instrument torque limiter FDA UDI
Model / Reference: Y1Z.35030 FDA UDI

Identifiers

Primary DI / UDI-DI: 08809539697451 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical instrument torque limiter 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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Surgical instrument torque limiter

Surgical Instrument by OSTEONIC CO., Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical instrument torque limiter.

Pisces-SA — OSSEUS FUSION SYSTEMS LLC · Class I
MobileLink Acetabular Cup System - Instruments — WALDEMAR LINK GmbH & Co. KG · Class I
Versalink Torque Limiter — PREMIA SPINE LTD · Class II
ST.A.R. 90 F4 — Citieffe · Class II
VersaLink Torque Limiter — PREMIA SPINE LTD · Class II
Titan Modular Shoulder System 2.5 — Smith & Nephew, Inc. · Class I
Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC. · Class I
CarboClear X Pedicle Screw System — CARBOFIX ORTHOPEDICS LTD · 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: OSTEONIC CO., Ltd.

Sources (1)

FDA UDI d1ee6e00-3365-4b9f-9553-566a2015ef6d 32 fields · synced May 30, 2026