Instinct Java System
FDA 510(k) K122592 · Zimmer Spine
510(k) numberK122592
Submission
- Device name
- Instinct Java System
- Applicant
- Zimmer Spine
Minneapolis, MN, US - Received
- August 24, 2012
- Decision date
- January 4, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MNH – Orthosis, Spondylolisthesis Spinal Fixation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3070
- Specialty
- Orthopedic
- Implant
- Yes
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| K143013 | Spinal Inner Fixation SystemMNH · Traditional | Changzhou Dingjian Medical Appliance Co., Ltd. | 12/11/2015SE |
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Questions and answers
When was Instinct Java System cleared by the FDA?
Instinct Java System (K122592) received a 510(k) decision of Substantially Equivalent on January 4, 2013, 133 days after the submission was received.
What is the product code of K122592?
The FDA product code is MNH – Orthosis, Spondylolisthesis Spinal Fixation, a Class II (moderate risk) device regulated under 21 CFR 888.3070.