510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K092901Substantially Equivalent

Epicage Interbody Fusion Device

R Tree Innovations, Apple Valley MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K092901 is the FDA 510(k) clearance record for EPICAGE INTERBODY FUSION DEVICE, a class II device, cleared for R Tree Innovations on under FDA product code MAX (Intervertebral Fusion Device With Bone Graft, Lumbar). FDA's definition for product code MAX reads: "Intended to stabilize spinal segment to promote fusion in order to restrict motion and decrease pain using bone graft". FDA records list one 510(k) clearance for R Tree Innovations. As of , FDA records show no recalls naming K092901.

Clearance record

Decision date
Received
(219 days to decision)
Product code
MAX Intervertebral Fusion Device With Bone Graft, Lumbar
Regulation
21 CFR 888.3080
Device class
Class II
Review panel
Orthopedic
Applicant
R Tree Innovations 13540 Guild Ave., Apple Valley MN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MAX

Trailing 12 months
19 clearances under product code MAX in the twelve months to October 2026, May 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code MAX, trailing twelve months
MonthClearances
November 20251
December 20251
January 20262
February 20263
March 20260
April 20261
May 20265
June 20261
July 20264
August 20261
September 20260
October 20260