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JAZZ System Connector Kit

by Implanet 7 variants

JAZZ System Connector Kit (350200) is a Class II device made by Implanet, cleared under FDA 510(k) K191217 on 2 Aug 2019 (5 earlier submissions) and listed in FDA GUDID since 23 Sep 2015 (UDI-DI 03607503502009), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK191217 Date2 Aug 2019DecidedStatusActive
United StatesGUDID listing Number03607503502009 UDI-DI Date23 Sep 2015ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • FDA 510(k) K191217 decided 2 Aug 2019 Active· +5 more in the status table
  • FDA GUDID UDI-DI 03607503502009 listed 23 Sep 2015 Listed

Timeline

7 dated events

  1. Cleared FDA 510(k) K151740
  2. Listed FDA GUDID 03607503502009
  3. Cleared FDA 510(k) K160226
  4. Cleared FDA 510(k) K170730
  5. Cleared FDA 510(k) K171881
  6. Cleared FDA 510(k) K182771
  7. Cleared FDA 510(k) K191217

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
JAZZ System
Generic name
Trans-facet-screw internal spinal fixation system, sterile
Model / Ref / Catalog
Connector Kit, 350200
Primary DI / UDI-DI
03607503502009
510(k) Number
FDA product code
OWI
GMDN term
Trans-facet-screw internal spinal fixation system, sterile
Device class
Class II
Regulation number
888.3010
GUDID distribution status
In Commercial Distribution
Size
Lumen/Inner Diameter — 3.5 Millimeter

Related devices

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

Cleared under the same submission (K151740)

and 8 more cleared under K151740

Cleared under the same submission (K160226)

and 8 more cleared under K160226

Similar devices

Other devices filed under FDA product code OWI (Bone Fixation Cerclage, Sublaminar).

Other devices from Implanet

See all devices from Implanet →

Properties

  • Supplied sterile
  • Single use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)