Seurat

FDA UDI

Class II (US FDA UDI)

by CTL Medical Corporation

Identity

Trade Name: SEURAT FDA UDI
Generic Name: Spinal bone screw, non-bioabsorbable FDA UDI
Device Name: SEURAT Screw Body, HEX4.0, Cannulated, D6.0xL60mm FDA UDI
Model / Reference: 126.1761 FDA UDI
Description: SEURAT Screw Body, HEX4.0, Cannulated, D6.0xL60mm FDA UDI

Identifiers

Primary DI / UDI-DI: 00841732148024 FDA UDI
510(k) Number: K173185 FDA UDI
FDA Product Code: NKB FDA UDI
KWP FDA UDI
KWQ FDA UDI
GMDN Term: Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3070 FDA UDI
888.3050 FDA UDI
888.3060 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

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal bone screw, non-bioabsorbable

The SEURAT spinal fixation system is a robust and reliable solution for internal spinal stabilization, providing long-lasting results through the use of non-bioabsorbable screws. With its durable design and adjustable drive options, this device is ideal for treating various spinal conditions, including degenerative disc disease and herniated discs. Developed by CTL Medical Corporation, SEURAT has undergone rigorous testing to ensure its safety and efficacy.

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

K173185 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: CTL Medical Corporation

Sources (1)

FDA UDI 667df3c4-b169-4906-ac27-cfb0b0e670ee 35 fields · synced Jul 15, 2026