510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K111469Substantially Equivalent

Staxxsd System

Spine Wave Inc, Shelton CT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K111469 is the FDA 510(k) clearance record for STAXXSD SYSTEM, a class II device, cleared for Spine Wave, Inc. on under FDA product code MQP (Spinal Vertebral Body Replacement Device). FDA records list 59 510(k) clearances for Spine Wave, Inc., from to . As of , FDA records show no recalls naming K111469.

Clearance record

Decision date
Received
(53 days to decision)
Product code
MQP Spinal Vertebral Body Replacement Device
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Spine Wave, Inc. 3 Enterprise Dr., Shelton CT
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