Apelo® / Apelo® MIS

FDA UDI

Class I (US FDA UDI)

by Atlas Spine Inc.

Identity

Trade Name: Apelo® / Apelo® MIS FDA UDI
Generic Name: Bone-resection orthopaedic reamer, reusable FDA UDI
Device Name: Cannulated Head Grooming Tool FDA UDI
Model / Reference: 2010-06-0000 FDA UDI
Description: Cannulated Head Grooming Tool FDA UDI

Identifiers

Catalog Number: 2010-06-0000 FDA UDI
Primary DI / UDI-DI: M68120100600000 FDA UDI
FDA Product Code: HTO FDA UDI
GMDN Term: Bone-resection orthopaedic reamer, reusable 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

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

MRI Safety

MR Conditional FDA UDI

Category: Bone-resection orthopaedic reamer, reusable

Apelo® / Apelo® MIS by Atlas Spine Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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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: Atlas Spine Inc.

Sources (1)

FDA UDI 7f360468-9965-4883-bc40-6843580a3c2a 35 fields · synced May 30, 2026