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HARRIER-SA Lumbar Interbody System

FDA UDI

Class II (US FDA UDI)

by Choicespine, LP

Identity

Trade Name
HARRIER-SA Lumbar Interbody System FDA UDI
Generic Name
Spinal bone screw, non-bioabsorbable FDA UDI
Device Name
HARRIER-SA,SCREW,5.0X40 FDA UDI
Model / Reference
YT30-5040 FDA UDI
Description
HARRIER-SA,SCREW,5.0X40 FDA UDI

Identifiers

Primary DI / UDI-DI
00840996171199 FDA UDI
510(k) Number
K180519 FDA UDI
FDA Product Code
MAX FDA UDI
OVD FDA UDI
GMDN Term
Spinal bone screw, non-bioabsorbable FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
888.3080 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

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

Dimensions & Sizes

Size
Outer Diameter — 5 Millimeter FDA UDI
Length — 40 Millimeter FDA UDI

Category: Spinal bone screw, non-bioabsorbable

HARRIER-SA Lumbar Interbody System by Choicespine, LP — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Spinal bone screw, non-bioabsorbable.

Cleared under the same submission

K180519 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Choicespine, LP

Sources (1)

  • FDA UDI 1b1b137e-5ad8-40e0-a5fb-2b5d4ed3028a 36 fields · synced May 30, 2026