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AccelFix Spinal Fixation System

FDA UDI

Class II (US FDA UDI)

by L&K Biomed Co. , Ltd.

Identity

Trade Name
AccelFix Spinal Fixation System FDA UDI
Generic Name
Bone-screw internal spinal fixation system connector FDA UDI
Device Name
Crosslink (Bar) 40-52mm, T: 3.5 FDA UDI
Model / Reference
1044-3552 FDA UDI
Description
Crosslink (Bar) 40-52mm, T: 3.5 FDA UDI

Identifiers

Catalog Number
1044-3552 FDA UDI
Primary DI / UDI-DI
08800061349818 FDA UDI
510(k) Number
K182544 FDA UDI
FDA Product Code
NKB FDA UDI
KWP FDA UDI
KWQ FDA UDI
GMDN Term
Bone-screw internal spinal fixation system connector FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3070 FDA UDI
888.3050 FDA UDI
888.3060 FDA UDI
Commercial Distribution
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

Category: Bone-screw internal spinal fixation system connector

AccelFix Spinal Fixation System by L&K Biomed Co. , Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Bone-screw internal spinal fixation system connector.

Cleared under the same submission

K182544 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 a6d8de08-33f6-4eaf-9443-c334baaf80d2 35 fields · synced May 30, 2026