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CastleLoc Spinal Fixation System/LnK Basic Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by L&K Biomed Co. , Ltd.

Identity

Trade Name
CastleLoc Spinal Fixation System/LnK Basic Spinal Fixation System FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
Poly Axial Screw(Non-Self Tapping) Ø6.5, 95mm FDA UDI
Model / Reference
1521-6595 FDA UDI
Description
Poly Axial Screw(Non-Self Tapping) Ø6.5, 95mm FDA UDI

Identifiers

Catalog Number
1521-6595 FDA UDI
Primary DI / UDI-DI
08806344326934 FDA UDI
510(k) Number
K162801 FDA UDI
FDA Product Code
MNH FDA UDI
MNI FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

Yes

FDA UDI

Contains Latex

No

FDA UDI

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

CastleLoc Spinal Fixation System/LnK Basic Spinal Fixation System by L&K Biomed Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID

Cleared under the same submission

K162801 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
L&K Biomed Co. , Ltd.

Sources (1)

  • FDA UDI 5b42e352-8b5e-494e-8635-b6b81a29a298 36 fields · synced May 31, 2026