Cervalign

FDA UDI

Class II (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name: Cervalign FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: CervAlign, 2 LEVEL, 24MM FDA UDI
Model / Reference: 66-224 FDA UDI
Description: CervAlign, 2 LEVEL, 24MM FDA UDI

Identifiers

Primary DI / UDI-DI: 00810076561134 FDA UDI
510(k) Number: K211408 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

MRI Safety

MR Conditional FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

Cervalign by Xtant Medical Holdings, Inc. — 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
CODA™ Anterior Cervical Plate System — Pioneer Surgical Technology, Inc. · Class II
TSLP — Synthes · Class II
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

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: Xtant Medical Holdings, Inc.

Sources (1)

FDA UDI 6849fcc9-3480-4481-95df-873d72fb8525 35 fields · synced May 30, 2026