SPIRA™-C Open Matrix Cervical Interbody

FDA UDI

Class II (US FDA UDI)

by Camber Spine Technologies

Identity

Trade Name: SPIRA™-C Open Matrix Cervical Interbody FDA UDI
Generic Name: Metallic spinal fusion cage, non-sterile FDA UDI
Device Name: 12.5mm x 16mm, Anatomic, 10mm FDA UDI
Model / Reference: SPC-12516-AN10 FDA UDI
Description: 12.5mm x 16mm, Anatomic, 10mm FDA UDI

Identifiers

Primary DI / UDI-DI: B030SPC12516AN100 FDA UDI
510(k) Number: K172446 FDA UDI
FDA Product Code: ODP FDA UDI
GMDN Term: Metallic spinal fusion cage, non-sterile 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

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

Yes

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size: Depth — 12.5 Millimeter FDA UDI
Width — 16 Millimeter FDA UDI
Height — 10 Millimeter FDA UDI

Category: Metallic spinal fusion cage, non-sterile

SPIRA™-C Open Matrix Cervical Interbody by Camber Spine Technologies — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Metallic spinal fusion cage, non-sterile.

Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
Silverstone Titanium Interbody Fusion System — Altus Spine · Class II
TraXis® — ZIMMER SPINE, INC. · Class II
PLIF Cage — Eisertech, LLC · Class II
IVA Cage Ti — Dio Medical Co., Ltd. · Class II
Copperhead — EMINENT SPINE LLC · Class II
IVA Cage Ti — Dio Medical Co., Ltd. · Class II
3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC · Class II

Cleared under the same submission

K172446 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: Camber Spine Technologies

Sources (1)

FDA UDI 6c4f4479-b1ba-4efd-ab4d-abed6326e9ab 36 fields · synced May 30, 2026