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JAZZ System

FDA UDI

Class II (US FDA UDI)

by Implanet

Identity

Trade Name
JAZZ System FDA UDI
Generic Name
Trans-facet-screw internal spinal fixation system, sterile FDA UDI
Model / Reference
Jazz Screw - Polyaxial Screw Dia.5.5 L55 FDA UDI

Identifiers

Catalog Number
350610 FDA UDI
Primary DI / UDI-DI
03607503506106 FDA UDI
510(k) Number
K182771 FDA UDI
K191217 FDA UDI
FDA Product Code
NKB FDA UDI
OWI FDA UDI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3010 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Lumen/Inner Diameter — 5.5 Millimeter FDA UDI
Length — 55 Millimeter FDA UDI

Category: Trans-facet-screw internal spinal fixation system, sterile

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

Similar devices

Also classified as Trans-facet-screw internal spinal fixation system, sterile.

Cleared under the same submission

K182771 also covers:

K191217 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Implanet

Sources (1)

  • FDA UDI 899ff732-3d31-4917-9e15-2ce5fd95e1c9 35 fields · synced May 30, 2026