The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Cemented Origin Hip Stem.
| Device ID | K201951 |
| 510k Number | K201951 |
| Device Name: | Cemented Origin Hip Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Metal/ceramic/polymer, Cemented Or Non-porous, Uncemented |
| 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 | LZO |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-13 |
| Decision Date | 2020-07-31 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215054755 | K201951 | 000 |
| 09348215054564 | K201951 | 000 |
| 09348215081423 | K201951 | 000 |
| 09348215081416 | K201951 | 000 |
| 09348215081126 | K201951 | 000 |
| 09348215081119 | K201951 | 000 |
| 09348215081102 | K201951 | 000 |
| 09348215081096 | K201951 | 000 |
| 09348215081089 | K201951 | 000 |
| 09348215081072 | K201951 | 000 |
| 09348215081065 | K201951 | 000 |
| 09348215081058 | K201951 | 000 |
| 09348215081041 | K201951 | 000 |
| 09348215081034 | K201951 | 000 |
| 09348215081027 | K201951 | 000 |
| 09348215081010 | K201951 | 000 |
| 09348215054571 | K201951 | 000 |
| 09348215054588 | K201951 | 000 |
| 09348215054595 | K201951 | 000 |
| 09348215054748 | K201951 | 000 |
| 09348215054731 | K201951 | 000 |
| 09348215054724 | K201951 | 000 |
| 09348215054717 | K201951 | 000 |
| 09348215054700 | K201951 | 000 |
| 09348215054694 | K201951 | 000 |
| 09348215054687 | K201951 | 000 |
| 09348215054670 | K201951 | 000 |
| 09348215054663 | K201951 | 000 |
| 09348215054656 | K201951 | 000 |
| 09348215054649 | K201951 | 000 |
| 09348215054632 | K201951 | 000 |
| 09348215054625 | K201951 | 000 |
| 09348215054618 | K201951 | 000 |
| 09348215054601 | K201951 | 000 |
| 09348215081003 | K201951 | 000 |