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Kora Spinal System MRHP7070

by Medyssey Co., Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

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

Overview

The Kora Spinal System is a high-performance, threaded implantable rod used for internal spinal fixation in orthopedic treatment. Made from surgical steel or titanium alloy, it provides optimal stability and immobilization of spinal segments.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08809214540416 UDI-DI Date13 Jun 2025ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Kora Spinal System
Generic Name
Spinal bone screw, non-bioabsorbable
Model / Reference
MRHP7070
Primary DI / UDI-DI
08809214540416
FDA Product Code
MNH, MNI
GMDN Term
Spinal bone screw, non-bioabsorbable
Device Class
Class II
Regulation Number
888.3070
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Spinal bone screw, non-bioabsorbable

Other devices from Medyssey Co., Ltd.

See all devices from Medyssey Co., Ltd. →

Properties

  • Single Use
  • Implantable
  • Lot / Batch Number
  • Manufacturing Date

Other properties (10)

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