TRANSLACE™ Spinal Tethering System
Bone Fixation Cerclage, Sublaminar
Medtronic Sofamor Danek USA, Inc.
The following data is part of a premarket notification filed by Medtronic Sofamor Danek Usa, Inc. with the FDA for Translace™ Spinal Tethering System.
Pre-market Notification Details
| Device ID | K163181 |
| 510k Number | K163181 |
| Device Name: | TRANSLACE™ Spinal Tethering System |
| Classification | Bone Fixation Cerclage, Sublaminar |
| Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Contact | Becky Ronner |
| Correspondent | Claire Evans Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
| Product Code | OWI |
| CFR Regulation Number | 888.3010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-14 |
| Decision Date | 2017-05-16 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00643169742949 | K163181 | 000 |
| 00763000333386 | K163181 | 000 |
| 00763000333393 | K163181 | 000 |
| 00763000333409 | K163181 | 000 |
| 00763000099701 | K163181 | 000 |
| 00763000108380 | K163181 | 000 |
| 00763000108397 | K163181 | 000 |
| 00643169726918 | K163181 | 000 |
| 00643169726925 | K163181 | 000 |
| 00643169726932 | K163181 | 000 |
| 00763000108403 | K163181 | 000 |
Trademark Results [TRANSLACE]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 TRANSLACE 87469368 5612843 Live/Registered |
Warsaw Orthopedic, Inc. 2017-05-31 |
 TRANSLACE 86456468 not registered Dead/Abandoned |
Warsaw Orthopedic, Inc. 2014-11-17 |
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