Pipeline II Access System
FDA 510(k) K062814 · Depuy Spine, Inc.
510(k) numberK062814
Submission
- Device name
- Pipeline II Access System
- Applicant
- Depuy Spine, Inc.
Raynham, MA, US - Received
- September 20, 2006
- Decision date
- December 15, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Pipeline II Access System cleared by the FDA?
Pipeline II Access System (K062814) received a 510(k) decision of Substantially Equivalent on December 15, 2006, 86 days after the submission was received.
What is the product code of K062814?
The FDA product code is GZT – Retractor, Self-Retaining, For Neurosurgery, a Class II (moderate risk) device regulated under 21 CFR 882.4800.