Xspan Laminoplasty Fixation System

FDA UDI

Class II (US FDA UDI)

by Xtant Medical Holdings, Inc.

Identity

Trade Name: Xspan Laminoplasty Fixation System FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: 10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT, UNSLOTTED FDA UDI
Model / Reference: X085-0310-H04-RU-STR FDA UDI
Description: 10mm PLATE, LAMINOPLASTY, ANGLED RIGHT, with HOOK, 4mm THROAT, UNSLOTTED FDA UDI

Identifiers

Primary DI / UDI-DI: M697X0850310H04RUSTR1 FDA UDI
510(k) Number: K160114 FDA UDI
FDA Product Code: NQW FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3050 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

FDA UDI

Manufacturing Date

FDA UDI

Sterilization Method

Radiation Sterilization FDA UDI

Dimensions & Sizes

Size: Length — 10 Millimeter FDA UDI
Depth — 4 Millimeter FDA UDI

Category: Spinal fixation plate, non-bioabsorbable

Xspan Laminoplasty Fixation System is a non-customized, implantable spinal fixation plate designed for the treatment of various spinal instabilities or deformities. It provides immobilization and stabilization of spinal segments in anterior/posterior cervical, lumbar, thoracolumbar, and occipital fixation procedures.

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

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Xtant Medical Holdings, Inc.

Sources (1)

FDA UDI 56d86e0c-72e4-4098-a55e-af3fc174bd16 36 fields · synced Jul 30, 2026