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Bone Fixation Screw Kit 112-080 KIT

by Jeil Medical Corporation

Bone Fixation Screw Kit 112-080 KIT is a Class II device made by Jeil Medical Corporation, cleared under FDA 510(k) K050669 on 26 May 2005 and listed in FDA GUDID since 25 Jul 2017 (UDI-DI 08806390852135), 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) K050669

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 Number08806390852135 UDI-DI Date25 Jul 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK050669 Date26 May 2005DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K050669 decided 26 May 2005 Active
  • FDA GUDID UDI-DI 08806390852135 listed 25 Jul 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K050669
  2. Listed FDA GUDID 08806390852135

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bone Fixation Screw Kit
Generic name
Craniofacial fixation plate kit, non-bioabsorbable
Model / reference
112-080 KIT
Primary DI / UDI-DI
08806390852135
510(k) Number
FDA product code
DZL
GMDN term
Craniofacial fixation plate kit, non-bioabsorbable
Device class
Class II
Regulation number
872.4880
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Craniofacial fixation plate kit, non-bioabsorbable

Cleared under the same submission (K050669)

and 8 more cleared under K050669

Similar devices

Other devices filed under FDA product code DZL (Screw, Fixation, Intraosseous).

Other devices from Jeil Medical Corporation

See all devices from Jeil Medical Corporation →

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)