Atlas FDA

Lumbar Interbody Fusion System (OLLIF)

FDA 510(k) clearance K173947 · decided 2018-07-25

Clearance details

K-number
K173947
Device name
Lumbar Interbody Fusion System (OLLIF)
Applicant
Advanced Research Medical, LLC
Decision
Substantially Equivalent
Date received
2017-12-27
Decision date
2018-07-25
Days to decision
210 days
Clearance type
Traditional
Product code
MAX
Device class
2
Regulation number
888.3080
Medical specialty
Orthopedic
Advisory committee
Orthopedic
Location
Burnsville, MN, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Advanced Research Medical

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
TruLift Expandable System (K261430)Life Spine, Inc.2026-07-28
Catalyft PL Expandable Interbody System (K253011)Medtronic Sofamor Danek USA, Inc.2026-07-17
Symmetrix™ L Spinal System (K261020)Medtronic Sofamor Danek USA, Inc.2026-07-14
Admiral ACP System; Explorer TO System; Laminoplasty System; Manta Ray TDF Spacer; Meridian Interbody System; Meridian Anterior Plate System; Reef L Interbody System; Reef TO/TA System; Regatta Lateral System; Regatta Lateral Plate System; Shoreline ACS Interbody System; Shoreline Threaded TruProfile Plate; Shoreline RT Interbody System; Vu Mesh; WaveForm A Interbody System; WaveForm C Interbody System; WaveForm L Interbody System; WaveForm TA Interbody System; WaveForm TO Interbody Sy (K253420)SeaSpine Orthopedics Corporation2026-07-01
Fule Interbody Fusion Cage System (K253151)Beijing Fule Science & Technology Development Co., Ltd.2026-06-15
Exceed® Biplanar Expandable Interbody System (K261159)Spine Wave, Inc.2026-05-29
BMD Titanium Spinal Fusion System (K253894)Global Biomedica s.r.o.2026-05-28
Ventana® P/T Lumbar Interbody System (K260506)Spinal Elements, Inc.2026-05-15
VersaLift Expandable System (K260837)Life Spine, Inc.2026-05-12
aprevo® anterior and lateral lumbar interbody system; aprevo® posterior and transforaminal lumbar interbody system; aprevo® cervical interbody system; corra™ cervical plating system (K260385)Carlsmed, Inc.2026-05-09
BEE PLIF Cage (K261067)NGMedical GmbH2026-04-30
SWINGO-3D Lumbar Cage System (K254017)Implanet2026-02-26

Recalls involving this device

RecordFirmDate
ADVANCED RESEARCH MEDICAL Lumbar Interbody Fusion System (OLLIF), Flexible Curette Loop Bl recall (Z-1698-2024)Advanced Research Medical, LLC2024-04-29