Apelo® / Apelo® MIS

FDA UDI

Class II (US FDA UDI)

by Atlas Spine Inc.

Identity

Trade Name: Apelo® / Apelo® MIS FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: 5.5mm x 50mm MIS Contoured Rod FDA UDI
Model / Reference: 1100-16-0050 FDA UDI
Description: 5.5mm x 50mm MIS Contoured Rod FDA UDI

Identifiers

Catalog Number: 1100-16-0050 FDA UDI
Primary DI / UDI-DI: M68111001600500 FDA UDI
510(k) Number: K110842 FDA UDI
FDA Product Code: NKB FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

Yes

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

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

Dimensions & Sizes

Size: Length — 50 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbable

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

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

4CIS® Chiron Spinal Fixation System — ALPHANOX CO., LTD. · Class II
LnK/PathLoc-L MIS Spinal System — L&K BIOMED CO. , LTD. · Class II
ASPIRON™ ACPSYSTEM — CG MedTech Co., Ltd. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
OpenLoc-L Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Sterile and Non Sterile Spinal System — Shandong Weigao Orthopaedic Device Company Limited. · Class IIb
AccelFix Spinal Fixation System (Sterile) — L&K Biomed · Class IIb
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II

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

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Manufacturer

Manufacturer: Atlas Spine Inc.

Sources (1)

FDA UDI 03eb4b90-f8aa-4689-a36f-8c807452b5fe 37 fields · synced Jun 7, 2026