Acetabular Reamer Driver, Straight

FDA UDI

Class I (US FDA UDI)

by Total Joint Orthopedics, Inc.

Identity

Trade Name: Acetabular Reamer Driver, Straight FDA UDI
Generic Name: Acetabular orthopaedic reamer FDA UDI
Device Name: Acetabular Reamer Driver, Straight FDA UDI
Model / Reference: 1208.00.000 FDA UDI
Description: Acetabular Reamer Driver, Straight FDA UDI

Identifiers

Primary DI / UDI-DI: 00819251020985 FDA UDI
FDA Product Code: LXH FDA UDI
GMDN Term: Acetabular orthopaedic reamer 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

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 handle, non-torque-limiting Acetabular orthopaedic reamer

Acetabular Reamer Driver, Straight by Total Joint Orthopedics, Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Cormet 2000 Hemi-Hip Metallic Resurfacing Prosthesis — CORIN LTD · Class II
ACETABULAR REAMER D82 mm HC — HPF SRL · Class I
iTotal® Hip Replacement System — Conformis, Inc. · Class II
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U2 Total Knee System — United Orthopedic Corporation · Class IIa

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

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Manufacturer

Manufacturer: Total Joint Orthopedics, Inc.

Sources (1)

FDA UDI 9a53a805-8b58-4330-bc5c-f452da5ad26e 35 fields · synced Jun 8, 2026