The following data is part of a premarket notification filed by Signature Orthopaedics Pty Ltd. with the FDA for Arlington Plif/tlif Cage.
| Device ID | K172020 |
| 510k Number | K172020 |
| Device Name: | Arlington PLIF/TLIF Cage |
| Classification | Intervertebral Fusion Device With Bone Graft, Lumbar |
| 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 | MAX |
| CFR Regulation Number | 888.3080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-07-05 |
| Decision Date | 2017-11-29 |
| Summary: | summary |