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JAZZ System Universal Snapping Forceps

by Implanet 2 variants

JAZZ System Universal Snapping Forceps (550061) 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 24 Sep 2015 (UDI-DI 03607505500614), 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 Number03607505500614 UDI-DI Date24 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 03607505500614 listed 24 Sep 2015 Listed

Timeline

7 dated events

  1. Cleared FDA 510(k) K151740
  2. Listed FDA GUDID 03607505500614
  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  • Withdrawn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
Implant handling forceps, scissors-like
Model / Ref / Catalog
Universal Snapping Forceps, 550061
Primary DI / UDI-DI
03607505500614
FDA product code
OWI
GMDN term
Implant handling forceps, scissors-like
Device class
Class II
Regulation number
888.3010
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

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

Other devices from Implanet

See all devices from Implanet →

Properties

  • Sterilise before use
  • Lot / batch number
Other properties (13, all answered No)