510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K102853Substantially Equivalent

Flamenco Spinal Fixation System

Ulrich GmbH & Co. KG, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K102853 is the FDA 510(k) clearance record for FLAMENCO SPINAL FIXATION SYSTEM, a class II device, cleared for Ulrich GmbH & Co. KG on under FDA product code MNH (Orthosis, Spondylolisthesis Spinal Fixation). FDA records list 24 510(k) clearances for Ulrich GmbH & Co. KG, from to . As of , FDA records show one recall naming K102853.

Clearance record

Decision date
Received
(118 days to decision)
Product code
MNH Orthosis, Spondylolisthesis Spinal Fixation
Regulation
21 CFR 888.3070
Device class
Class II
Review panel
Orthopedic
Applicant
Ulrich GmbH & Co. KG 754 Spirit 40 Park Dr., St. Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code MNH

Trailing 12 months

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

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