CoFix Implant 8 mm

FDA UDI

Class II (US FDA UDI)

by Paradigm Spine, LLC

Identity

Trade Name: CoFix Implant 8 mm FDA UDI
Generic Name: Interspinous spinal fixation implant FDA UDI
Model / Reference: RQI00008 FDA UDI

Identifiers

Catalog Number: RQI00008 FDA UDI
Primary DI / UDI-DI: 04260148898235 FDA UDI
510(k) Number: K153302 FDA UDI
FDA Product Code: PEK FDA UDI
GMDN Term: Interspinous spinal fixation implant FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 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

MRI Safety

MR Conditional FDA UDI

Dimensions & Sizes

Size: Height — 8 Millimeter FDA UDI

Category: Interspinous spinal fixation implant

CoFix Implant 8 mm by Paradigm Spine, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Interspinous spinal fixation implant.

Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
ASPEN MIS FUSION SYSTEM — BIOMET SPINE LLC · Class II
Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
Benefix™ Interspinous Fixation System — CG MedTech Co., Ltd. · Class II
Axle Interspinous Fusion System — Xtant Medical Holdings, Inc. · Class II
InFill V2 Lateral PE — PINNACLE SPINE GROUP, LLC · Class II

Cleared under the same submission

K153302 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

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Manufacturer

Manufacturer: Paradigm Spine, LLC

Sources (1)

FDA UDI 4e272bc2-eab7-4c73-9c43-6cf19723b525 35 fields · synced Jun 1, 2026