Arcos Modular Revision System

FDA UDI

Class II (US FDA UDI)

by Biomet Orthopedics, Inc.

Identity

Trade Name: ARCOS MODULAR REVISION SYSTEM FDA UDI
Generic Name: Medullary canal orthopaedic reamer, flexible FDA UDI
Model / Reference: 31-301827 FDA UDI

Identifiers

Catalog Number: 31-301827 FDA UDI
Primary DI / UDI-DI: 00880304483699 FDA UDI
510(k) Number: K090757 FDA UDI
FDA Product Code: MAY FDA UDI
KWY FDA UDI
LZO FDA UDI
JDI FDA UDI
LPH FDA UDI
MEH FDA UDI
KWZ FDA UDI
GMDN Term: Medullary canal orthopaedic reamer, flexible FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3353 FDA UDI
888.3390 FDA UDI
888.3350 FDA UDI
888.3358 FDA UDI
888.3310 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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medullary canal orthopaedic reamer, flexible

Arcos Modular Revision System by Biomet Orthopedics, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Medullary canal orthopaedic reamer, flexible.

MODULAR FLEXIBLE REAMER HEAD, Ø10.0mm — ADVANCED ORTHOPAEDIC SOLUTIONS, INC. · Class II
Patella Inlay Reamer Size 5 — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
Arthrex® — Arthrex, Inc. · Class I
Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class I
OIC Intramedullary Nail System — ORTHOPAEDIC IMPLANT COMPANY, THE · Class II
World Stem Reamer Size 5-6M — SIGNATURE ORTHOPAEDICS PTY LTD · Class I
Arthrex® — Arthrex, Inc. · Class I
Tapered Pin Reamer — SIGNATURE ORTHOPAEDICS PTY LTD · Class I

Cleared under the same submission

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

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

Manufacturer

Manufacturer: Biomet Orthopedics, Inc.

Sources (1)

FDA UDI e7b46fb3-4b0c-4abb-bfb6-849d7f7a1d0c 36 fields · synced May 30, 2026