Novel Spinal Spacer System

FDA UDI

Class II (US FDA UDI)

by Alphatec Spine, Inc.

Identity

Trade Name: Novel Spinal Spacer System FDA UDI
Generic Name: Polymeric spinal interbody fusion cage FDA UDI
Device Name: Novel VC 40-50 mm PEEK, M-10, 40 mm, 10deg Lordosis FDA UDI
Model / Reference: 64353-340 FDA UDI
Description: Novel VC 40-50 mm PEEK, M-10, 40 mm, 10deg Lordosis FDA UDI

Identifiers

Primary DI / UDI-DI: 00844856012332 FDA UDI
510(k) Number: K080699 FDA UDI
FDA Product Code: MAX FDA UDI
MQP FDA UDI
GMDN Term: Polymeric spinal interbody fusion cage FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3080 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

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

Dimensions & Sizes

Size: Height — 40 Millimeter FDA UDI
Length — 32 Millimeter FDA UDI
Width — 20 Millimeter FDA UDI
Angle — 10 degree FDA UDI

Category: Polymeric spinal interbody fusion cage

Novel Spinal Spacer System by Alphatec Spine, Inc. — 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
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
Peridot Intervertebral body fusion system — GBS Commonwealth Co., Ltd. · Class II

Cleared under the same submission

K080699 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: Alphatec Spine, Inc.

Sources (1)

FDA UDI 6a5689cd-3d5d-4256-8da2-0ae03b6fd00f 36 fields · synced Jun 8, 2026