510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K090425Substantially Equivalent

Guided Lateral Interbody Fusion (Glif) System

Alphatec Spine, Inc., Carlsnad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K090425 is the FDA 510(k) clearance record for GUIDED LATERAL INTERBODY FUSION (GLIF) SYSTEM, a class II device, cleared for Alphatec Spine, Inc. 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 121 510(k) clearances for Alphatec Spine, Inc., from to . As of , FDA records show no recalls naming K090425.

Clearance record

Decision date
Received
(89 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
Alphatec Spine, Inc. 5818 El Camino Real, Carlsnad CA
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 November 2026, May 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code MAX, trailing twelve months
MonthClearances
December 20251
January 20262
February 20263
March 20260
April 20261
May 20265
June 20261
July 20264
August 20261
September 20260
October 20261
November 20260