Submission Details
| 510(k) Number | K173320 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 20, 2017 |
| Decision Date | February 23, 2018 |
| Days to Decision | 126 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
KLS Martin L1 MMF System
Feb 2018
Decision
126d
Days
Class 2
Risk
About This 510(k) Submission
K173320 is an FDA 510(k) clearance for the KLS Martin L1 MMF System, a Plate, Bone (Class II — Special Controls, product code JEY), submitted by KLS-Martin L.P. (Jacksonville, US). The FDA issued a Cleared decision on February 23, 2018, 126 days after receiving the submission on October 20, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.4760.
Device Classification
| Product Code | JEY — Plate, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4760 |
Manufacturer
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