Submission Details
| 510(k) Number | K151195 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 04, 2015 |
| Decision Date | September 21, 2015 |
| Days to Decision | 140 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
Cleared
Traditional
OsteoMed IMF Screw
Sep 2015
Decision
140d
Days
Class 2
Risk
About This 510(k) Submission
K151195 is an FDA 510(k) clearance for the OsteoMed IMF Screw, a Screw, Fixation, Intraosseous (Class II — Special Controls, product code DZL), submitted by Osteomed (Addison, US). The FDA issued a Cleared decision on September 21, 2015, 140 days after receiving the submission on May 4, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.4880.
Device Classification
| Product Code | DZL — Screw, Fixation, Intraosseous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 872.4880 |
Manufacturer
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