JAZZ System

FDA UDI

Class II (US FDA UDI)

by Implanet

Identity

Trade Name: JAZZ System FDA UDI
Generic Name: Spinal implant trial FDA UDI
Model / Reference: JAZZ Claw-Hook Trial Right FDA UDI

Identifiers

Catalog Number: 560337 FDA UDI
Primary DI / UDI-DI: 10889981188481 FDA UDI
510(k) Number: K191217 FDA UDI
FDA Product Code: OWI FDA UDI
GMDN Term: Spinal implant trial FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 888.3010 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

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 implant trial

JAZZ System by Implanet — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

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Also classified as Spinal implant trial.

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IdentiTi — ALPHATEC SPINE, INC. · Class II
MLX — Nuvasive, Inc. · Class I
IdentiTi — ALPHATEC SPINE, INC. · Class II
ROI-A — Ldr Spine USA · Class II

Cleared under the same submission

K191217 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: Implanet

Sources (1)

FDA UDI 27740c74-6b97-4f57-9d11-d83b06f72fb5 34 fields · synced Jun 1, 2026