Submission Details
| 510(k) Number | K113346 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 14, 2011 |
| Decision Date | February 28, 2012 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
NEON SYSTEM
Feb 2012
Decision
106d
Days
Class 2
Risk
About This 510(k) Submission
K113346 is an FDA 510(k) clearance for the NEON SYSTEM, a Appliance, Fixation, Spinal Interlaminal (Class II — Special Controls, product code KWP), submitted by Ulrich GmbH & Co. KG (Chesterfield, US). The FDA issued a Cleared decision on February 28, 2012, 106 days after receiving the submission on November 14, 2011. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3050.
Device Classification
| Product Code | KWP — Appliance, Fixation, Spinal Interlaminal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3050 |
Manufacturer
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