Tslp

FDA UDI

Class II (US FDA UDI)

by Synthes

Identity

Trade Name: TSLP FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: TI THORACOLUMBAR SPINE LOCKING PLATE 55MM FDA UDI
Model / Reference: 489.456 FDA UDI
Description: TI THORACOLUMBAR SPINE LOCKING PLATE 55MM FDA UDI

Identifiers

Catalog Number: 489456 FDA UDI
Primary DI / UDI-DI: 10705034784533 FDA UDI
510(k) Number: K020244 FDA UDI
FDA Product Code: KWQ FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 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

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

Tslp by Synthes — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal fixation plate, non-bioabsorbable.

Zavation — ZAVATION · Class II
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AESCULAP — AESCULAP, INC. · Class II
PROVIDENCE — GLOBUS MEDICAL, INC. · Class II
ACP — Nuvasive, Inc. · Class II
uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · Class II
Rexious — Dio Medical Co., Ltd. · Class II

Cleared under the same submission

K020244 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: Synthes

Sources (1)

FDA UDI 2270eee0-bbad-4ace-821a-7a5ae025acbc 36 fields · synced May 30, 2026