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JAZZ System

FDA UDI

Class II (US FDA UDI)

by Implanet

Identity

Trade Name
JAZZ System FDA UDI
Generic Name
Internal spinal fixation system cable tensioner FDA UDI
Device Name
Tensioner Gen. II - 135° Stem FDA UDI
Model / Reference
Tensioner Gen. II - 135° Stem FDA UDI
Description
Tensioner Gen. II - 135° Stem FDA UDI

Identifiers

Catalog Number
550300 FDA UDI
Primary DI / UDI-DI
03607505503004 FDA UDI
510(k) Number
K151740 FDA UDI
K160226 FDA UDI
K170730 FDA UDI
K171881 FDA UDI
K182771 FDA UDI
K191217 FDA UDI
FDA Product Code
OWI FDA UDI
GMDN Term
Internal spinal fixation system cable tensioner 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

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Angle — 135 degree FDA UDI

Category: Internal spinal fixation system cable tensioner

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

Similar devices

Also classified as Internal spinal fixation system cable tensioner.

Cleared under the same submission

K151740 also covers:

K160226 also covers:

K170730 also covers:

K171881 also covers:

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 85b13fd3-9dfc-41fd-b69e-d4ccf05e475d 36 fields · synced May 30, 2026