510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183197Substantially Equivalent

PYRAMESH™ Implant System

Medtronic Sofamor Danek USA Inc, Memphis TN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183197 is the FDA 510(k) clearance record for PYRAMESH™ Implant System, a class II device, cleared for Medtronic Sofamor Danek USA, Inc. on under FDA product code MQP (Spinal Vertebral Body Replacement Device). FDA records list 182 510(k) clearances for Medtronic Sofamor Danek USA, Inc., from to . As of , FDA records show no recalls naming K183197.

Clearance record

Decision date
Received
(136 days to decision)
Product code
MQP Spinal Vertebral Body Replacement Device
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Pl., Memphis TN
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MQP

Trailing 12 months
3 clearances under product code MQP in the twelve months to October 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MQP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20262
August 20260
September 20260
October 20260