Osteotec CBG Soft Tissue Displacer Large

FDA UDI

Class I (US FDA UDI)

by Osteotec, Ltd.

Identity

Trade Name: Osteotec CBG Soft Tissue Displacer Large FDA UDI
Generic Name: Surgical drill guide obturator FDA UDI
Device Name: To minimize soft tissue damage, two different size displacers have been included in the kit. The two parts are slotted together and then pushed through the soft tissue until the bone is reached. The central part of the displacer can then be removed, and the tube saw can be inserted. This will stop the saw teeth from ‘snagging’ on and damaging the soft tissue and thus help reduce the recovery time. FDA UDI
Model / Reference: OST-CBG-22 FDA UDI
Description: To minimize soft tissue damage, two different size displacers have been included in the kit. The two parts are slotted together and then pushed through the soft tissue until the bone is reached. The central part of the displacer can then be removed, and the tube saw can be inserted. This will stop the saw teeth from ‘snagging’ on and damaging the soft tissue and thus help reduce the recovery time. FDA UDI

Identifiers

Catalog Number: OST-CBG-22 FDA UDI
Primary DI / UDI-DI: 05060183095762 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Surgical drill guide obturator 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: Surgical drill guide obturator

Osteotec CBG Soft Tissue Displacer Large by Osteotec, Ltd. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Surgical drill guide obturator.

TRIGEN — Smith & Nephew, Inc. · Class I
DARCO — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
SMALL CANNULATED SCREWS — Smith & Nephew, Inc. · Class II
JUGGERKNOT FLEX OBTURATOR — Biomet Orthopedics, Inc. · Class II
NexFix — TORNIER, INC. · Class I
AM — WRIGHT MEDICAL TECHNOLOGY, INC. · Class I
Marina Medical — MARINA MEDICAL INSTRUMENTS, INC. · Class I
NexFix — TORNIER, INC. · Class I

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: Osteotec, Ltd.

Sources (1)

FDA UDI 513de534-7c4b-4fa2-9a91-463de0a527e5 34 fields · synced Jun 6, 2026