The following data is part of a premarket notification filed by Fusion Orthopedics with the FDA for Polylock Plating System.
| Device ID | K211843 |
| 510k Number | K211843 |
| Device Name: | PolyLock Plating System |
| Classification | Plate, Fixation, Bone |
| Applicant | Fusion Orthopedics 4135 S Powder Road Mesa, AZ 85212 |
| Contact | Eli Jacobson |
| Correspondent | Eli Jacobson Fusion Orthopedics 4135 S Powder Road Mesa, AZ 85212 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-15 |
| Decision Date | 2022-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840124511118 | K211843 | 000 |
| 00840124511101 | K211843 | 000 |
| 00840124506480 | K211843 | 000 |
| 00840124502468 | K211843 | 000 |
| 00840124502451 | K211843 | 000 |
| 00840124511354 | K211843 | 000 |
| 00840124511347 | K211843 | 000 |
| 00840124511361 | K211843 | 000 |
| 00840124511132 | K211843 | 000 |