The following data is part of a premarket notification filed by Endeavor Orthopaedics, Llc with the FDA for Summit Patella Plating System.
| Device ID | K203408 |
| 510k Number | K203408 |
| Device Name: | Summit Patella Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Endeavor Orthopaedics, LLC 11601 S Richmond Avenue Tulsa, OK 74137 |
| Contact | John Alleman |
| Correspondent | Alyssa Thomas Allegiance Regulatory Consulting LLC 16642 SW Lansford Ct. Beaverton, OR 97007 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-19 |
| Decision Date | 2021-07-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860004838012 | K203408 | 000 |
| 00860004838005 | K203408 | 000 |