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LineSider

FDA UDI

Class II (US FDA UDI)

by Integrity Implants Inc.

Identity

Trade Name
LineSider FDA UDI
Generic Name
Bone-screw internal spinal fixation system rod FDA UDI
Device Name
CoCr Rod - MIS - 5.0mm 95mm Curved FDA UDI
Model / Reference
LS-RD50E095 FDA UDI
Description
CoCr Rod - MIS - 5.0mm 95mm Curved FDA UDI

Identifiers

Catalog Number
LS-RD50E095 FDA UDI
Primary DI / UDI-DI
00810004725584 FDA UDI
510(k) Number
K190360 FDA UDI
FDA Product Code
KWP FDA UDI
NKB FDA UDI
GMDN Term
Bone-screw internal spinal fixation system rod FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3050 FDA UDI
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

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

LineSider by Integrity Implants Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Cleared under the same submission

K190360 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Integrity Implants Inc.

Sources (1)

  • FDA UDI b0a5108e-0b70-402a-b8d9-45969b930abc 37 fields · synced Jun 6, 2026