TiBow

FDA UDI

Class II (US FDA UDI)

by Life Spine, Inc.

Identity

Trade Name: TiBow FDA UDI
Generic Name: Surgical implant template, reusable FDA UDI
Model / Reference: 129-1203 FDA UDI

Identifiers

Catalog Number: 129-1203 FDA UDI
Primary DI / UDI-DI: 00190837069131 FDA UDI
510(k) Number: K170919 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Surgical implant template, reusable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

FDA UDI

Implantable

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: Surgical implant template, reusable

TiBow by Life Spine, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Surgical implant template, reusable.

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EVOS — Smith & Nephew, Inc. · Class I
Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I
VFT — Ldr Spine USA · Class II
Tranquil-C™ — NEXUS SPINE, L.L.C. · Class I

Cleared under the same submission

K170919 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: Life Spine, Inc.

Sources (1)

FDA UDI 1c322922-4e12-424b-afb2-e1dfdfaf0bfa 34 fields · synced Jun 8, 2026