510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K211769Substantially Equivalent

OneLIF Intervertebral Body Replacement System

Novapproach Spine LLC, Alachua FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K211769 is the FDA 510(k) clearance record for OneLIF Intervertebral Body Replacement System, a class II device, cleared for Novapproach Spine on under FDA product code OVD (Intervertebral Fusion Device With Integrated Fixation, Lumbar). FDA's definition for product code OVD reads: "Intended to stabilize lumbar spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft with or without supplemental fixation". FDA records list 2 510(k) clearances for Novapproach Spine, from to . As of , FDA records show 2 recalls naming K211769.

Clearance record

Decision date
Received
(91 days to decision)
Product code
OVD Intervertebral Fusion Device With Integrated Fixation, Lumbar
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
Novapproach Spine 13900 Tech City Cir., Alachua FL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVD

Trailing 12 months
9 clearances under product code OVD in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code OVD, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20261
May 20261
June 20261
July 20262
August 20261
September 20261
October 20260