Skip to content

KangLi Pedicle Screw Spinal System T6160400

by Suzhou Kangli Orthopaedics Instrument Co., Ltd. EUDAMEDGUDID

Active European Union EUDAMED: not on the EU market

Ref T6161400Model Non-sterile Spinal Systems(KSS-II, III Lumbar)

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number690295900030FD Basic UDI-DIDate25 Aug 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number06937762165071 UDI-DIDate3 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
KangLi EUDAMED
KangLi Pedicle Screw Spinal System GUDID
Generic Name
Bone-screw internal spinal fixation system rod
Device Name
Non-sterile Spinal Systems
Model / Ref / Catalog
Non-sterile Spinal Systems(KSS-II EUDAMED
III Lumbar) EUDAMED
T6161400 EUDAMED
T6160400 GUDID
Primary DI / UDI-DI
06937762165071
Basic UDI-DI
690295900030FD
Direct Marketing DI
06937762165071
510(k) Number
FDA Product Code
MNH, MNI
EMDN Code
P09070302 Thoracolumbosacral fixation systems
GMDN Term
Bone-screw internal spinal fixation system rod
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
888.3070
GUDID distribution status
Not in Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Length — 400 Millimeter

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Non-sterile Spinal Systems(KSS-II, III Lumbar)
T6161400
GUDID
T6160400
Device ClassEUDAMED
Class IIb
GUDID
Class II
SterileEUDAMED
No
GUDID
Yes

Other devices from Suzhou Kangli Orthopaedics Instrument Co., Ltd.

See all devices from Suzhou Kangli Orthopaedics Instrument Co., Ltd. →

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Implantable
  • Reprocessed
  • Sutures
  • Lot / Batch Number
  • Manufacturing Date

Other properties (18)

  • Reusable: No
  • Contains Latex: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: 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