Uni-Thread®

FDA UDI

Class II (US FDA UDI)

by Spine Vision, Inc.

Identity

Trade Name: UNI-THREAD® FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: Ti 5.5 mm 48-53 mm smooth screw with 6.5mm top FDA UDI
Model / Reference: L2-CH553T FDA UDI
Description: Ti 5.5 mm 48-53 mm smooth screw with 6.5mm top FDA UDI

Identifiers

Primary DI / UDI-DI: 03663136005034 FDA UDI
510(k) Number: K013301 FDA UDI
FDA Product Code: MNI FDA UDI
MNH 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

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

FDA UDI

Manufacturing Date

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Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal bone screw, non-bioabsorbable

At UNI-THREAD, we've revolutionized spinal fixation with our innovative, non-bioabsorbable screw that provides unparalleled stability and support for patients. With its unique design and advanced materials, this device has been carefully crafted to deliver exceptional results in the treatment of spinal instabilities and deformities. Our commitment to quality and patient care is reflected in every aspect of this product, from its sterilization methods to its comprehensive documentation.

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

K013301 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: Spine Vision, Inc.

Sources (1)

FDA UDI 2c78ccd0-2c0a-410d-bd56-002be382c96f 35 fields · synced Jul 9, 2026