510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K111913Substantially Equivalent

Capsure(r) Ps System

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

K111913 is the FDA 510(k) clearance record for CAPSURE(R) PS SYSTEM, a class II device, cleared for Spine Wave, Inc. on under FDA product code MNI (Orthosis, Spinal Pedicle Fixation). FDA records list 59 510(k) clearances for Spine Wave, Inc., from to . As of , FDA records show no recalls naming K111913.

Clearance record

Decision date
Received
(56 days to decision)
Product code
MNI Orthosis, Spinal Pedicle Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Spine Wave, Inc. Three Enterprise Dr., Shelton CT
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