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Apelo® / Apelo® MIS

FDA UDI

Class I (US FDA UDI)

by Atlas Spine Inc.

Identity

Trade Name
Apelo® / Apelo® MIS FDA UDI
Generic Name
Orthopaedic counter-torque/rod-pushing instrument FDA UDI
Device Name
MIS Counter Torque FDA UDI
Model / Reference
2012-78-0000 FDA UDI
Description
MIS Counter Torque FDA UDI

Identifiers

Catalog Number
2012-78-0000 FDA UDI
Primary DI / UDI-DI
M68120127800000 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Orthopaedic counter-torque/rod-pushing instrument 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

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI
MRI Safety
MR Conditional FDA UDI

Category: Orthopaedic counter-torque/rod-pushing instrument

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

Similar devices

Also classified as Orthopaedic counter-torque/rod-pushing instrument.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Atlas Spine Inc.

Sources (1)

  • FDA UDI 9e088a68-7888-4fc6-876a-19f2f7315b97 35 fields · synced Jun 1, 2026