The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Origin Coxa Vara Hip Stem.
| Device ID | K161155 |
| 510k Number | K161155 |
| Device Name: | Origin Coxa Vara Hip Stem |
| Classification | Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate |
| 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 | MEH |
| CFR Regulation Number | 888.3353 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-04-25 |
| Decision Date | 2016-07-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09348215055806 | K161155 | 000 |
| 09348215051877 | K161155 | 000 |
| 09348215051860 | K161155 | 000 |
| 09348215051853 | K161155 | 000 |
| 09348215051846 | K161155 | 000 |
| 09348215051839 | K161155 | 000 |
| 09348215051822 | K161155 | 000 |
| 09348215051815 | K161155 | 000 |
| 09348215051808 | K161155 | 000 |
| 09348215051792 | K161155 | 000 |
| 09348215051785 | K161155 | 000 |
| 09348215051778 | K161155 | 000 |
| 09348215051761 | K161155 | 000 |
| 09348215051754 | K161155 | 000 |
| 09348215051747 | K161155 | 000 |
| 09348215051884 | K161155 | 000 |
| 09348215051891 | K161155 | 000 |
| 09348215051907 | K161155 | 000 |
| 09348215083564 | K161155 | 000 |
| 09348215083557 | K161155 | 000 |
| 09348215083540 | K161155 | 000 |
| 09348215083533 | K161155 | 000 |
| 09348215092825 | K161155 | 000 |
| 09348215092818 | K161155 | 000 |
| 09348215092801 | K161155 | 000 |
| 09348215092795 | K161155 | 000 |
| 09348215092788 | K161155 | 000 |
| 09348215092771 | K161155 | 000 |
| 09348215092764 | K161155 | 000 |
| 09348215092757 | K161155 | 000 |
| 09348215092740 | K161155 | 000 |
| 09348215051914 | K161155 | 000 |
| 09348215051730 | K161155 | 000 |