510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180480Substantially Equivalent

ATEC Universal Spacer System

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

K180480 is the FDA 510(k) clearance record for ATEC Universal Spacer System, a class II device, cleared for Alphatec Spine, Inc. on under FDA product code PHM (Intervertebral Fusion Device With Bone Graft, Thoracic). FDA's definition for product code PHM reads: "Intended to stabilize thoracic 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 K180480.

Clearance record

Decision date
Received
(97 days to decision)
Product code
PHM Intervertebral Fusion Device With Bone Graft, Thoracic
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 PHM

Trailing 12 months

FDA records hold no clearances under product code PHM in the trailing twelve months.

FDA records show no clearances under product code PHM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PHM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260