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Newgen System

by Stryker Instruments

510(k) K002619

Newgen System is a Class II device made by Stryker Instruments, cleared under FDA 510(k) K002619 on 16 Nov 2000, active as of 11 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 11 Oct 2026.

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK002619 Date16 Nov 2000ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
JEY
Device class
Class II
Regulation
21 CFR Part 872.4760
Advisory committee
Dental
FDA decision
SESE Substantially Equivalent

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Other devices filed under FDA product code JEY (Plate, Bone).

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