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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
Surgical instrument handle, torque-limiting FDA UDI
Device Name
DLC Torque Limiting Handle FDA UDI
Model / Reference
2009-67-0000 FDA UDI
Description
DLC Torque Limiting Handle FDA UDI

Identifiers

Catalog Number
2009-67-0000 FDA UDI
Primary DI / UDI-DI
M68120096700000 FDA UDI
FDA Product Code
LXH FDA UDI
GMDN Term
Surgical instrument handle, torque-limiting 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: Surgical instrument handle, torque-limiting

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

Similar devices

Also classified as Surgical instrument handle, torque-limiting.

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 ff6afa6a-620b-4793-bcfd-609daeb8150d 35 fields · synced Jun 6, 2026