Restore Interbody Fusion System

FDA UDI

Class II (US FDA UDI)

by Republic Spine, LLC

Identity

Trade Name: Restore Interbody Fusion System FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: Small Lordotic TLIF Cage - PEEK 28mm(L) x 9mm(W) x 11mm(H) x 6*(A) FDA UDI
Model / Reference: 110022-28S1106P FDA UDI
Description: Small Lordotic TLIF Cage - PEEK 28mm(L) x 9mm(W) x 11mm(H) x 6*(A) FDA UDI

Identifiers

Catalog Number: RETL-28S1106P FDA UDI
Primary DI / UDI-DI: B07511002228S1106P0 FDA UDI
510(k) Number: K190398 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

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

MRI Safety

MR Unsafe FDA UDI

Dimensions & Sizes

Size: Width — 9 Millimeter FDA UDI
Height — 11 Millimeter FDA UDI
Length — 28 Millimeter FDA UDI

Category: Polymeric spinal interbody fusion cage

Restore Interbody Fusion System by Republic Spine, LLC — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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

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: Republic Spine, LLC

Sources (1)

FDA UDI 9d31b68e-75ae-494c-9343-4581dab7d50e 37 fields · synced May 30, 2026