Zero-P Natural Plate System
FDA 510(k) K152239 · Synthes (Usa), LLC
510(k) numberK152239
Submission
- Device name
- Zero-P Natural Plate System
- Applicant
- Synthes (Usa), LLC
Monument, CO, US - Received
- August 10, 2015
- Decision date
- December 2, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KWQ – Appliance, Fixation, Spinal Intervertebral Body
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.3060
- Specialty
- Orthopedic
- Implant
- Yes
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Questions and answers
When was Zero-P Natural Plate System cleared by the FDA?
Zero-P Natural Plate System (K152239) received a 510(k) decision of Substantially Equivalent on December 2, 2015, 114 days after the submission was received.
What is the product code of K152239?
The FDA product code is KWQ – Appliance, Fixation, Spinal Intervertebral Body, a Class II (moderate risk) device regulated under 21 CFR 888.3060.