MODULAR FLEXIBLE REAMER HEAD, Ø10.0mm

FDA UDI

Class II (US FDA UDI)

by Advanced Orthopaedic Solutions, Inc.

Identity

Trade Name: MODULAR FLEXIBLE REAMER HEAD, Ø10.0mm FDA UDI
Generic Name: Medullary canal orthopaedic reamer, flexible FDA UDI
Model / Reference: 0234-100 FDA UDI

Identifiers

Primary DI / UDI-DI: 00848665000870 FDA UDI
510(k) Number: K012190 FDA UDI
K021008 FDA UDI
K070444 FDA UDI
K103533 FDA UDI
K123569 FDA UDI
K132005 FDA UDI
K191598 FDA UDI
FDA Product Code: HSB FDA UDI
HTW FDA UDI
GMDN Term: Medullary canal orthopaedic reamer, flexible FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3020 FDA UDI
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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Medullary canal orthopaedic reamer, flexible

MODULAR FLEXIBLE REAMER HEAD, Ø10.0mm by Advanced Orthopaedic Solutions, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Dyna Locking IM Nail — CG MedTech Co., Ltd. · Class I
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Cleared under the same submission

K012190 also covers:

K021008 also covers:

K070444 also covers:

K103533 also covers:

K123569 also covers:

K132005 also covers:

K191598 also covers:

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

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Manufacturer

Manufacturer: Advanced Orthopaedic Solutions, Inc.

Sources (1)

FDA UDI b6bd3fa6-33ae-43c5-854d-8b74548ed3b3 34 fields · synced May 29, 2026