Medical Device Manufacturer · US , Minneapolis , MN

Signus Medizintechnik GmbH - FDA 510(k) Cleared Devices

23 submissions · 22 cleared · Since 1999
23
Total
22
Cleared
0
Denied

Signus Medizintechnik GmbH has 22 FDA 510(k) cleared orthopedic devices. Based in Minneapolis, US.

Latest FDA clearance: Feb 2025. Active since 1999.

Browse the complete list of FDA 510(k) cleared orthopedic devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by Jalex Medical, LLC and Kapstone Medical, LLC.

FDA 510(k) Regulatory Record - Signus Medizintechnik GmbH
23 devices
1-23 of 23
Cleared Feb 11, 2025
CYLOX® ST
K243188 · OVE
Orthopedic · 134d
Cleared Sep 11, 2024
Signus Tetris™ St
K241438 · MAX
Orthopedic · 113d
Cleared Nov 18, 2022
COSY Cervicothoracic Occipital Rod-Screw System
K220658 · NKG
Orthopedic · 256d
Cleared Mar 10, 2022
SIGNUS SACRONAIL® Transsacral Stabilization System
K212755 · HWC
Orthopedic · 191d
Cleared Apr 13, 2016
Diplomat® Spinal System
K151704 · NKB
Orthopedic · 294d
Cleared Sep 16, 2014
MOBIS II ST SPINAL IMPLANT
K141405 · MAX
Orthopedic · 111d
Cleared Jan 14, 2014
TASMIN R
K123758 · MQP
Orthopedic · 403d
Cleared Jul 02, 2013
MOBIS II
K131372 · MAX
Orthopedic · 50d
Cleared Aug 29, 2012
TETRIS II
K122317 · MAX
Orthopedic · 28d
Cleared Mar 05, 2012
MOBIS, MOVAL, SEMIAL, TETRISMODEL PEEK AND TITANIUM, KIMBA MODEL STANDARD AND...
K111792 · MAX
Orthopedic · 252d
Cleared Sep 28, 2009
KAINOS+
K090387 · MQV
Orthopedic · 223d
Cleared Jul 24, 2009
NUBIC AND RABEA DEVICES
K082848 · ODP
Orthopedic · 298d
Cleared Jun 10, 2008
ATHLET VERTEBRAL BODY REPLACEMENT SYSTEM
K081332 · MQP
Orthopedic · 29d
Cleared Apr 23, 2008
TOSCA II ANTERIOR CERVICAL PLATE SYSTEM
K080815 · KWQ
Orthopedic · 30d
Cleared Mar 10, 2008
KIMBA MINI
K080349 · MQP
Orthopedic · 28d
Cleared Dec 18, 2006
MOBIS SPINAL IMPLANT
K061082 · MQP
Orthopedic · 244d
Cleared Sep 14, 2006
OVALTWIST PEDICLE SCREW SYSTEM
K061577 · MNH
Orthopedic · 99d
Cleared Nov 03, 2005
KIMBA SPINAL IMPLANT
K052533 · MQP
Orthopedic · 49d
Cleared Jul 13, 2005
SEMIAL SPINAL IMPLANT
K051659 · MQP
Orthopedic · 21d
Cleared Feb 07, 2005
RABEA SPINAL IMPLANT
K043316 · MQP
Orthopedic · 67d
Cleared Nov 23, 2004
THE TOSCA ANTERIOR CERVICAL PLATE SYSTEM
K043082 · KWQ
Orthopedic · 15d
Cleared Aug 10, 2004
CURVED PEEK TETRIS SPINAL IMPLANT
K041888 · MQP
Orthopedic · 29d
Cleared Jul 30, 1999
RABEA DEVICE, MODEL PXXXXXX
K990345 · JDK
Orthopedic · 176d
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