510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K032094Substantially Equivalent

Passmed Spinal System

Medicrea, Round Rock TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K032094 is the FDA 510(k) clearance record for PASSMED SPINAL SYSTEM, a class II device, cleared for Medicrea on under FDA product code KWP (Appliance, Fixation, Spinal Interlaminal). FDA records list 4 510(k) clearances for Medicrea, from to . As of , FDA records show no recalls naming K032094.

Clearance record

Decision date
Received
(130 days to decision)
Product code
KWP Appliance, Fixation, Spinal Interlaminal
Regulation
21 CFR 888.3050
Device class
Class II
Review panel
Orthopedic
Applicant
Medicrea 1001 Oakwood Blvd., Round Rock TX
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KWP

Trailing 12 months

FDA records hold no clearances under product code KWP in the trailing twelve months.

FDA records show no clearances under product code KWP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code KWP, 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