Skip to content

Skyline 186852019

by Medos International Sàrl

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

7 closed

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number10705034134284 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

7 recalls · FDA

  • 7 recalls, same reason

    • Terminated Z-0625-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0630-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0624-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0626-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0629-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0628-2017 FDA Class II initiated 12 Oct 2016
    • Terminated Z-0627-2017 FDA Class II initiated 12 Oct 2016

    SKYLINE Variable Ti screws may have contained SKYLINE Constrained Ti screws within the packaging.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Skyline
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Ref / Catalog
186852019
Primary DI / UDI-DI
10705034134284
510(k) Number
FDA Product Code
KWQ
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3060
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Cleared under the same submission (K052552)

Show all (12)

Cleared under the same submission (K171439)

Show all (12)

Other devices from Medos International SARL

See all devices from Medos International SARL →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number

Other properties (10)

  • Sterile: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No