Harmony Port System, Model 1907 Series
FDA 510(k) K050706 · Spinal Concepts, Inc.
510(k) numberK050706
Submission
- Device name
- Harmony Port System, Model 1907 Series
- Applicant
- Spinal Concepts, Inc.
Austin, TX, US - Received
- March 18, 2005
- Decision date
- April 15, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K031855 | Spinal Concepts, Inc. Insight Pedicle Screw SystemKWQ · Traditional | 09/17/2003SE |
| K031985 | Spinal Concepts Inc. Nex-Link Spinal Fixation SystemMNI · Traditional | 09/11/2003SE |
| K031318 | Traxis Cement RestrictorJDK · Special | 08/22/2003SESU |
| K031672 | Spinal Concepts, Inc. Infix SystemMQP · Traditional | 08/07/2003SE |
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Questions and answers
When was Harmony Port System, Model 1907 Series cleared by the FDA?
Harmony Port System, Model 1907 Series (K050706) received a 510(k) decision of Substantially Equivalent on April 15, 2005, 28 days after the submission was received.
What is the product code of K050706?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.