Spartan Hip Stem
Prosthesis, Hip, Semi-constrained, Uncemented, Metal / Polymer, Non-porous, Calcium Phosphate
Signature Orthopaedics Pty Ltd.
The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Spartan Hip Stem.
Pre-market Notification Details
| Device ID | K192883 |
| 510k Number | K192883 |
| Device Name: | Spartan 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 | 2019-10-10 |
| Decision Date | 2020-08-05 |
NIH GUDID Devices
Trademark Results [Spartan Hip Stem]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SPARTAN HIP STEM 88805892 not registered Live/Pending |
Signature Orthopaedics Pty Ltd 2020-02-21 |
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