510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K894184Substantially Equivalent for Some Indications

Biedermann Motech Universal Spinal System

Biedermann Motech GmbH, Vs-Schwenningen, DE / Traditional, Substantially Equivalent for Some Indications
FDA source (opens on fda.gov)

K894184 is the FDA 510(k) clearance record for BIEDERMANN MOTECH UNIVERSAL SPINAL SYSTEM, a class II device, cleared for Biedermann Motech GmbH on under FDA product code JDN (Implant, Fixation Device, Spinal). FDA records list 2 510(k) clearances for Biedermann Motech GmbH, from to . As of , FDA records show no recalls naming K894184.

Clearance record

Decision date
Received
(313 days to decision)
Product code
JDN Implant, Fixation Device, Spinal
Regulation
21 CFR 888.3060
Device class
Class II
Review panel
Orthopedic
Applicant
Biedermann Motech GmbH Berta-Suttner-Strasse 23, Vs-Schwenningen, DE
Third party review
No

Clearances, product code JDN

Trailing 12 months

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

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