510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K153273Substantially Equivalent

MySpine Pedicle Screw Placement Guides - LP

Medacta International SA, Castel San Pietro, CH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K153273 is the FDA 510(k) clearance record for MySpine Pedicle Screw Placement Guides - LP, a class II device, cleared for Medacta International S.A. on under FDA product code MNI (Orthosis, Spinal Pedicle Fixation). FDA records list 205 510(k) clearances for Medacta International S.A., from to . As of , FDA records show no recalls naming K153273.

Clearance record

Decision date
Received
(230 days to decision)
Product code
MNI Orthosis, Spinal Pedicle Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Medacta International S.A. Strada Regina, Castel San Pietro, CH
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