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KangLi Pedicle Screw Spinal System

FDA UDIEUDAMED

Class II (US FDA UDI)

Ref T6236035Model Non-sterile Spinal Systems(KSS-II, III Lumbar)

by Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Identity

Trade Name
KangLi EUDAMED
KangLi Pedicle Screw Spinal System FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Non-sterile Spinal Systems EUDAMED
KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.0×35mm FDA UDI
Model / Reference
T6236035 EUDAMEDFDA UDI
Non-sterile Spinal Systems(KSS-II, III Lumbar) EUDAMED
Description
KSS 5.5 U-Multi-Axial Break-Off Pedicle Screw φ6.0×35mm FDA UDI

Identifiers

Catalog Number
T6236035 FDA UDI
Primary DI / UDI-DI
06937762182450 EUDAMEDFDA UDI
Basic UDI-DI
690295900030FD EUDAMED
Direct Marketing DI
06937762182450 EUDAMED
510(k) Number
K140053 FDA UDI
FDA Product Code
MNH FDA UDI
MNI FDA UDI
EMDN Code
P09070302 THORACOLUMBOSACRAL FIXATION SYSTEMS EUDAMED
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class IIb EUDAMED
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

Yes

EUDAMED

Sutures

Yes

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Length — 35 Millimeter FDA UDI

KangLi Pedicle Screw Spinal System by Suzhou Kangli Orthopaedics Instrument Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID, EUDAMED

Cleared under the same submission

K140053 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Suzhou Kangli Orthopaedics Instrument Co., Ltd.

Sources (2)

  • FDA UDI 8d0f86f3-9d47-49f3-b727-c0b82225b69b 36 fields · synced Oct 7, 2026
  • EUDAMED 75efe154-aed9-4594-a1d1-c8ebefc1ce33 61 fields · synced Jul 17, 2026