The following data is part of a premarket notification filed by Microport Navibot International Llc with the FDA for Skywalker Total Knee System.
| Device ID | K213873 |
| 510k Number | K213873 |
| Device Name: | SkyWalker Total Knee System |
| Classification | Orthopedic Stereotaxic Instrument |
| Applicant | MicroPort NaviBot International LLC 300 Foxborough Blvd. Foxborough, MA 02035 |
| Contact | Mike Manor |
| Correspondent | Jinmei Zhu Shanghai MicroPort Medical (Group) Co., Ltd. No. 1601 ZhangDong Road, ZJ Hi-Tech Park Shanghai, CN 201203 |
| Product Code | OLO |
| CFR Regulation Number | 882.4560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-13 |
| Decision Date | 2022-07-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850030914064 | K213873 | 000 |
| 10850030914146 | K213873 | 000 |
| 10850030914269 | K213873 | 000 |
| 10850030914276 | K213873 | 000 |
| 10850030914283 | K213873 | 000 |
| 00850030914309 | K213873 | 000 |
| 00850030914316 | K213873 | 000 |
| 00850030914323 | K213873 | 000 |
| 20850030914266 | K213873 | 000 |
| 20850030914273 | K213873 | 000 |
| 20850030914280 | K213873 | 000 |
| 00850030914040 | K213873 | 000 |
| 00850030914118 | K213873 | 000 |