← Back to catalogue

Lumbar Interbody Fusion System (OLLIF)

FDA 510(k)FDA UDI

Class II (US FDA 510(k))

510(k) K173947

by Advanced Research Medical Llc

Identity

Trade Name
Lumbar Interbody Fusion System (OLLIF) FDA UDI
Generic Name
Instrument tray, reusable FDA UDI
Device Name
Lumbar Interbody Fusion System (OLLIF) Instrument Set in Graphic Sterilization Case FDA UDI
Model / Reference
01-2000 FDA UDI
Description
Lumbar Interbody Fusion System (OLLIF) Instrument Set in Graphic Sterilization Case FDA UDI

Identifiers

Catalog Number
01-2000 FDA UDI
Primary DI / UDI-DI
00850014575021 FDA UDI
510(k) Number
K173947 FDA 510(k)FDA UDI
FDA Product Code
MAX FDA 510(k)FDA UDI
GMDN Term
Instrument tray, reusable FDA UDI

Classification

Device Class
Class II FDA 510(k)FDA UDI
Legislation / Framework
21 CFR Part 888.3080 FDA 510(k)
Regulation Number
888.3080 FDA 510(k)FDA UDI
Advisory Committee
Orthopedic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

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

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Lumbar Interbody Fusion System (OLLIF) by Advanced Research Medical Llc — Class II — FDA_510K — listed in FDA 510(k), FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Advanced Research Medical Llc
FDA Applicant
Advanced Research Medical, LLC

Sources (2)

  • FDA 510(k) K173947 24 fields · synced Jun 18, 2026
  • FDA UDI 2db12098-0179-40c3-954e-c05d244d028e 36 fields · synced May 26, 2026