Skip to content

Zavation Sequential Reducer 989-1040

by Zavation GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00197157014681 UDI-DIDate3 Jun 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Zavation Sequential Reducer
Generic Name
General external orthopaedic fixation system implantation kit, reusable
Model / Reference
989-1040
Primary DI / UDI-DI
00197157014681
510(k) Number
FDA Product Code
LXH
GMDN Term
General external orthopaedic fixation system implantation kit, reusable
Device Class
Class I
Regulation Number
888.4540
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: General external orthopaedic fixation system implantation kit, reusable

Cleared under the same submission (K243908)

Show all (12)

Other devices from Zavation

See all devices from Zavation →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: 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