Zuma-L™

FDA UDI

Class II (US FDA UDI)

by SeaSpine Orthopedics Corporation

Identity

Trade Name: Zuma-L™ FDA UDI
Generic Name: Spinal fixation plate, non-bioabsorbable FDA UDI
Device Name: Zuma-L Implant, 45mm x 18mm x 12mm, 8 Deg FDA UDI
Model / Reference: 56-4512 FDA UDI
Description: Zuma-L Implant, 45mm x 18mm x 12mm, 8 Deg FDA UDI

Identifiers

Catalog Number: 56-4512 FDA UDI
Primary DI / UDI-DI: 10889981059316 FDA UDI
510(k) Number: K082926 FDA UDI
FDA Product Code: OVD FDA UDI
MQP FDA UDI
GMDN Term: Spinal fixation plate, non-bioabsorbable 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

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

Category: Spinal fixation plate, non-bioabsorbable

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

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Also classified as Spinal fixation plate, non-bioabsorbable.

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uNion Cervical Plate System — ULRICH MEDICAL USA, INC. · 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 5077faba-6339-4b0d-ba10-3710d60d599f 37 fields · synced Jun 8, 2026