The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Imboki Knee Instrument System.
| Device ID | K181338 |
| 510k Number | K181338 |
| Device Name: | Imboki Knee Instrument System |
| Classification | Prosthesis, Knee, Patellofemorotibial, Semi-constrained, Cemented, Polymer/metal/polymer |
| Applicant | Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove, AU 2066 |
| Contact | Declan Brazil |
| Correspondent | Declan Brazil Signature Orthopaedics Pty Ltd. 7 Sirius Road Lane Cove, AU 2066 |
| Product Code | JWH |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-05-21 |
| Decision Date | 2019-01-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215046392 | K181338 | 000 |
| 09348215031718 | K181338 | 000 |
| 09348215046194 | K181338 | 000 |
| 09348215046248 | K181338 | 000 |
| 09348215046279 | K181338 | 000 |
| 09348215046378 | K181338 | 000 |
| 09348215046408 | K181338 | 000 |
| 09348215031633 | K181338 | 000 |
| 09348215046200 | K181338 | 000 |
| 09348215046217 | K181338 | 000 |
| 09348215046224 | K181338 | 000 |
| 09348215046231 | K181338 | 000 |
| 09348215046255 | K181338 | 000 |
| 09348215031664 | K181338 | 000 |