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Spotlight 282912120

by Depuy Spine, Inc.

Spotlight 282912120 is a Class II device made by Depuy Spine, Inc., cleared under FDA 510(k) K062814 on 15 Dec 2006 and listed in FDA GUDID since 30 Jun 2016 (UDI-DI 10705034205670), active as of 23 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 23 Oct 2026

Documents

510(k) K062814

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705034205670 UDI-DI Date30 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK062814 Date15 Dec 2006DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K062814 decided 15 Dec 2006 Active
  • FDA GUDID UDI-DI 10705034205670 listed 30 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K062814
  2. Listed FDA GUDID 10705034205670

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Spotlight
Generic name
Endoscopic light source unit, line-powered
Model / Ref / Catalog
282912120
Primary DI / UDI-DI
10705034205670
510(k) Number
FDA product code
GZT
GMDN term
Endoscopic light source unit, line-powered
Device class
Class II
Regulation number
882.4800
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Endoscopic light source unit, line-powered

Cleared under the same submission (K062814)

and 8 more cleared under K062814

Similar devices in this category

Other devices filed under Endoscopic light source unit, line-powered.

Other devices from Depuy Spine, Inc.

See all devices from Depuy Spine, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)