510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K111294Substantially Equivalent

Santorini Spinal System

K2M, Inc, Leesburg VA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111294 is the FDA 510(k) clearance record for SANTORINI SPINAL SYSTEM, a class II device, cleared for K2m, Inc. on under FDA product code MQP (Spinal Vertebral Body Replacement Device). FDA records list 123 510(k) clearances for K2m, Inc., from to . As of , FDA records show no recalls naming K111294.

Clearance record

Decision date
Received
(262 days to decision)
Product code
MQP Spinal Vertebral Body Replacement Device
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
K2m, Inc. 751 Miller Dr. SE, Leesburg VA
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 November 2026, July 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code MQP, trailing twelve months
MonthClearances
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20262
August 20260
September 20260
October 20260
November 20260