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JAZZ System

by Implanet 41 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 21 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 21 Oct 2026. What this means

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number03607503506212 UDI-DI Date20 Mar 2019ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 21 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Generic Name
Trans-facet-screw internal spinal fixation system, sterile
Model / Ref / Catalog
Jazz Screw - Polyaxial Screw Dia.6.5 L50, 350621
Primary DI / UDI-DI
03607503506212
510(k) Number
FDA Product Code
NKB, OWI
GMDN Term
Trans-facet-screw internal spinal fixation system, sterile
Device Class
Class II
Regulation Number
888.3070, 888.3010
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 6.5 Millimeter
Length — 50 Millimeter

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

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Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No