Submission Details
| 510(k) Number | K201336 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 20, 2020 |
| Decision Date | September 03, 2020 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Orthopedic (OR) |
| Summary | Summary PDF |
Cleared
Traditional
DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm
Sep 2020
Decision
106d
Days
Class 2
Risk
About This 510(k) Submission
K201336 is an FDA 510(k) clearance for the DePuy Synthes Tibial Nail Advanced, Depuy Synthes Locking Screws Medullary Nails, 4.0 and 5.0mm, a Nail, Fixation, Bone (Class II — Special Controls, product code JDS), submitted by Synthes USA Products, LLC (19380, US). The FDA issued a Cleared decision on September 3, 2020, 106 days after receiving the submission on May 20, 2020. This device falls under the Orthopedic review panel. Regulated under 21 CFR 888.3030.
Device Classification
| Product Code | JDS — Nail, Fixation, Bone |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 888.3030 |
Manufacturer
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