The following data is part of a premarket notification filed by Synthes Usa, Llc with the FDA for Depuy Synthes Maxframe Multi-axial Correction System.
| Device ID | K161417 |
| 510k Number | K161417 |
| Device Name: | DePuy Synthes MAXFRAME Multi-Axial Correction System |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | SYNTHES USA, LLC 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Contact | Stacey Bonnell |
| Correspondent | Stacey Bonnell SYNTHES USA, LLC 1301 GOSHEN PARKWAY West Chester, PA 19380 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-23 |
| Decision Date | 2016-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
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