MEDICON Spinal Spreading Systems
FDA 510(k) K161680 · Medicon EG
510(k) numberK161680
Submission
- Device name
- MEDICON Spinal Spreading Systems
- Applicant
- Medicon EG
Tuttlingen, DE - Received
- June 17, 2016
- Decision date
- March 24, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K180610 | Geister retractor for neuro - and spine surgeryGZT · Traditional | Geister Medizin Technik GmbH | 08/29/2018SE |
| K172433 | NICO BrainPathGZT · Special | Nico Corporation | 09/07/2017SE |
| K161318 | Phantom Fukushima Neurological Holding Systems, Phantom Mastability Neurological Holding…GZT · Traditional | Tedan Surgical Innovations, LLC | 03/20/2017SE |
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| K150378 | NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's HookGZT · Traditional | Nico Corporation | 06/12/2015SE |
| K120691 | Brain PortGZT · Traditional | Nico Corporation | 06/05/2012SE |
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| K010910 | Medicon Yasargil Clip Applying ForcepsHCI · Traditional | 08/01/2001SE |
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Questions and answers
When was MEDICON Spinal Spreading Systems cleared by the FDA?
MEDICON Spinal Spreading Systems (K161680) received a 510(k) decision of Substantially Equivalent on March 24, 2017, 280 days after the submission was received.
What is the product code of K161680?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.