The following data is part of a premarket notification filed by Link Bio Corp. with the FDA for Instruments For Link Megasystem-c Family.
| Device ID | K190181 |
| 510k Number | K190181 |
| Device Name: | Instruments For LINK MEGASYSTEM-C Family |
| Classification | Prosthesis, Knee, Femorotibial, Constrained, Cemented, Metal/polymer |
| Applicant | Link Bio Corp. 101 Roundhill Drive Rockaway, NJ 07866 |
| Contact | Terry Powell |
| Correspondent | Terry Powell Link Bio Corp. 101 Roundhill Drive Rockaway, NJ 07866 |
| Product Code | KRO |
| Subsequent Product Code | JDI |
| Subsequent Product Code | LWJ |
| Subsequent Product Code | LZO |
| CFR Regulation Number | 888.3510 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-10-25 |
| Summary: | summary |