510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K100138Substantially Equivalent

Zodiac Polyaxial Spinal Fixation System

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

K100138 is the FDA 510(k) clearance record for ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM, a class II device, cleared for Alphatec Spine, Inc. on under FDA product code MNI (Orthosis, Spinal Pedicle Fixation). FDA records list 121 510(k) clearances for Alphatec Spine, Inc., from to . As of , FDA records show no recalls naming K100138.

Clearance record

Decision date
Received
(29 days to decision)
Product code
MNI Orthosis, Spinal Pedicle Fixation
Regulation
21 CFR 888.3070
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 MNI

Trailing 12 months

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

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