← Back to catalogue

KASILOF Cervical Plate System

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K203154

by Kahtnu Surgical, Inc.

Identity

Trade Name
KASILOF Cervical Plate System FDA UDI
Generic Name
Bone-screw internal spinal fixation system, non-sterile FDA UDI
Device Name
KASILOF CERVICAL PLATE, 5 LEVEL, 110mm FDA UDI
Model / Reference
KCP1-5110 FDA UDI
Description
KASILOF CERVICAL PLATE, 5 LEVEL, 110mm FDA UDI

Identifiers

Primary DI / UDI-DI
B644KCP151100 FDA UDI
510(k) Number
K203154 FDA 510(k)FDA UDI
FDA Product Code
KWQ FDA 510(k)FDA UDI
GMDN Term
Bone-screw internal spinal fixation system, non-sterile FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3060 FDA 510(k)
Regulation Number
888.3060 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

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

No

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

KASILOF Cervical Plate System by Kahtnu Surgical, Inc. — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Kahtnu Surgical, Inc.

Sources (2)

  • FDA 510(k) K203154 24 fields · synced Oct 10, 2026
  • FDA UDI 000f6d69-6813-40d8-be0e-98b478b7d3f6 34 fields · synced May 27, 2026