The following data is part of a premarket notification filed by Synthes (usa) Products, Llc with the FDA for Maxframe Multi-axial Correction System (aka Maxframe).
| Device ID | K211313 |
| 510k Number | K211313 |
| Device Name: | MAXFRAME Multi-Axial Correction System (aka MAXFRAME) |
| Classification | Appliance, Fixation, Nail/blade/plate Combination, Multiple Component |
| Applicant | Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Contact | Suchitra Basu |
| Correspondent | Suchitra Basu Synthes (USA) Products, LLC 1301 Goshen Parkway West Chester, PA 19380 |
| Product Code | KTT |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-30 |
| Decision Date | 2021-05-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07612334226563 | K211313 | 000 |