Copperhead

FDA UDI

Class II (US FDA UDI)

by Eminent Spine Llc

Identity

Trade Name: Copperhead FDA UDI
Generic Name: Metallic spinal fusion cage, non-sterile FDA UDI
Model / Reference: C5512 FDA UDI

Identifiers

Primary DI / UDI-DI: B014C5512 FDA UDI
510(k) Number: K090064 FDA UDI
FDA Product Code: ODP FDA UDI
MQP FDA UDI
MAX 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
888.3060 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

Category: Metallic spinal fusion cage, non-sterile

Copperhead by Eminent Spine Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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IVA Cage Ti — Dio Medical Co., Ltd. · Class II
3DP Lumbar Interbody System — Genesys Orthopedics Systems LLC · Class II

Cleared under the same submission

K090064 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: Eminent Spine Llc

Sources (1)

FDA UDI 1e50251b-713f-427a-a6dd-31583da103e8 33 fields · synced Jun 8, 2026