Omnia Medical TiBrid™-L

FDA UDI

Class II (US FDA UDI)

by Omnia Medical

Identity

Trade Name: Omnia Medical TiBrid™-L FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: LATERAL INTERBODY, 22x55x12mm, 15° FDA UDI
Model / Reference: 13-0L-225512-15 FDA UDI
Description: LATERAL INTERBODY, 22x55x12mm, 15° FDA UDI

Identifiers

Catalog Number: 13-0L-225512-15 FDA UDI
Primary DI / UDI-DI: 00843511107086 FDA UDI
510(k) Number: K190363 FDA UDI
FDA Product Code: MAX FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage 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

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

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Manufacturing Date

FDA UDI

Dimensions & Sizes

Size: Width — 22 Millimeter FDA UDI
Length — 55 Millimeter FDA UDI
Height — 12 Millimeter FDA UDI
Angle — 15 degree FDA UDI

Category: Polymeric spinal interbody fusion cage

A comprehensive guide to the Omnia Medical TiBrid-L medical device, including its features and regulatory compliance.

Similar devices

Also classified as Polymeric spinal interbody fusion cage.

L-Box® — Innovasis, Inc. · Class II
CoRoent — Nuvasive, Inc. · Class II
Novel Spinal Spacer System — ALPHATEC SPINE, INC. · Class II
S-LIFT® — SPINEFRONTIER, INC. · Class II
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II
TAURUS PEEK Cage System — Medyssey Co., Ltd. · Class II
Cross-Fuse® II PEEK IBF System — Rti Surgical, Inc. · Class II
Kyocera Medical Technologies, Inc. — Kyocera Medical Technologies, Inc. · Class II

Cleared under the same submission

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: Omnia Medical

Sources (1)

FDA UDI 99a910b7-bf10-4755-9a88-b5f12eb53a23 37 fields · synced Jul 30, 2026