510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K022768Substantially Equivalent

Amt Polyaxial Pedicle Screw

Micron Precision Engineering, Inc., San Pedro CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K022768 is the FDA 510(k) clearance record for AMT POLYAXIAL PEDICLE SCREW, a class II device, cleared for Micron Precision Engineering, Inc. on under FDA product code MNI (Orthosis, Spinal Pedicle Fixation). FDA records list 2 510(k) clearances for Micron Precision Engineering, Inc., from to . As of , FDA records show no recalls naming K022768.

Clearance record

Decision date
Received
(84 days to decision)
Product code
MNI Orthosis, Spinal Pedicle Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Micron Precision Engineering, Inc. 939 Evening Shade Dr., San Pedro 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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code MNI, 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