Zuma

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Zuma FDA UDI
Generic Name: Vertebral body prosthesis, non-sterile FDA UDI
Device Name: Zuma Implant, 26mm x 24mm x 20mm, 12 deg FDA UDI
Model / Reference: 55-2720 FDA UDI
Description: Zuma Implant, 26mm x 24mm x 20mm, 12 deg FDA UDI

Identifiers

Catalog Number: 55-2720 FDA UDI
Primary DI / UDI-DI: 10889981076245 FDA UDI
510(k) Number: K082926 FDA UDI
FDA Product Code: MQP FDA UDI
OVD FDA UDI
GMDN Term: Vertebral body prosthesis, non-sterile FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3060 FDA UDI
888.3080 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

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

FDA UDI

Sterilization Method

Moist Heat or Steam Sterilization FDA UDI

Category: Vertebral body prosthesis, non-sterile

Zuma by SeaSpine Orthopedics Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Vertebral body prosthesis, non-sterile.

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HONOUR™ Spacer System — NEXXT SPINE LLC · 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: SeaSpine Orthopedics Corporation

Sources (1)

FDA UDI 8034c7cd-5084-489c-8279-8df6df2fa71e 37 fields · synced Jun 8, 2026