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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
Intervertebral-body internal spinal fixation system FDA UDI
Device Name
HARRIER-SA,ST,SPACER,Ti,26X32X15,15DEG FDA UDI
Model / Reference
S-YT10-26321515 FDA UDI
Description
HARRIER-SA,ST,SPACER,Ti,26X32X15,15DEG FDA UDI

Identifiers

Primary DI / UDI-DI
00840996171434 FDA UDI
510(k) Number
K180519 FDA UDI
FDA Product Code
MAX FDA UDI
OVD FDA UDI
GMDN Term
Intervertebral-body internal spinal fixation system 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

Yes

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

Yes

FDA UDI

Manufacturing Date

Yes

FDA UDI

Dimensions & Sizes

Size
Width — 32 Millimeter FDA UDI
Depth — 26 Millimeter FDA UDI
Height — 15 Millimeter FDA UDI

Category: Intervertebral-body internal spinal fixation system

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 Intervertebral-body internal spinal fixation system.

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 61b4b36d-7439-40fb-9404-3a2a8f1d49aa 36 fields · synced May 30, 2026