ConneX Cross Connector

FDA UDI

Class II (US FDA UDI)

by Spineology Inc.

Identity

Trade Name: ConneX Cross Connector FDA UDI
Generic Name: Bone-screw internal spinal fixation system rod FDA UDI
Device Name: Cross Connector, Adjustable FDA UDI
Model / Reference: 10-10-82-2 FDA UDI
Description: Cross Connector, Adjustable FDA UDI

Identifiers

Catalog Number: 680-2531 FDA UDI
Primary DI / UDI-DI: M7406802531 FDA UDI
510(k) Number: K170251 FDA UDI
K170255 FDA UDI
K170266 FDA UDI
K170268 FDA UDI
FDA Product Code: MNH FDA UDI
MNI FDA UDI
NKB FDA UDI
GMDN Term: Bone-screw internal spinal fixation system rod 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

Yes

FDA UDI

Single Use

Yes

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

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Ethylene Oxide FDA UDI

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Length — 25 Millimeter FDA UDI

Category: Bone-screw internal spinal fixation system rod

ConneX Cross Connector by Spineology Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system rod.

The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
LnK Spinal Fixation System — L&K BIOMED CO. , LTD. · Class II
Whistler Modular Pedicle Screw System — EVOLUTION SPINE, LLC · Class II
Proficient® Posterior Cervical Spine System — Spine Wave, Inc. · Class II
Proficient™ Posterior Cervical Spine System — Spine Wave, Inc. · Class II
The JASPER Spinal Fixation System60 — GBS Commonwealth Co., Ltd. · Class II
The JASPER Spinal Fixation System — GBS Commonwealth Co., Ltd. · Class II
Fortex Pedicle Screw System — Xtant Medical Holdings, Inc. · Class II

Cleared under the same submission

K170266 also covers:

K170268 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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Spineology Inc.

Sources (1)

FDA UDI 02869c81-ee6f-454f-95e5-e01a12747696 37 fields · synced May 30, 2026