The following data is part of a premarket notification filed by Ascension Orthopedic with the FDA for Integra Titanium Bone Wedge.
| Device ID | K131360 |
| 510k Number | K131360 |
| Device Name: | INTEGRA TITANIUM BONE WEDGE |
| Classification | Plate, Fixation, Bone |
| Applicant | ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754 |
| Contact | Kyla Kara |
| Correspondent | Kyla Kara ASCENSION ORTHOPEDIC 8700 CAMERON RD., STE. 100 Austin, TX 78754 |
| Product Code | HRS |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-13 |
| Decision Date | 2013-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10381780124948 | K131360 | 000 |
| M269TRL1006C051 | K131360 | 000 |
| M269TRL1006C041 | K131360 | 000 |
| M269TRL1006C031 | K131360 | 000 |
| M269TRL1006C021 | K131360 | 000 |
| M269TRL1006C011 | K131360 | 000 |
| M269TRL1006L091 | K131360 | 000 |
| M269TRL1006L081 | K131360 | 000 |
| M269TRL1006L071 | K131360 | 000 |
| M269TRL1006L061 | K131360 | 000 |
| M269TRL1006L051 | K131360 | 000 |
| M269TRL1006L041 | K131360 | 000 |
| M269TRL1006L031 | K131360 | 000 |
| M269TRL1006L021 | K131360 | 000 |
| M269TRL1006C061 | K131360 | 000 |
| 10381780124801 | K131360 | 000 |
| 10381780124931 | K131360 | 000 |
| 10381780124924 | K131360 | 000 |
| 10381780124917 | K131360 | 000 |
| 10381780124900 | K131360 | 000 |
| 10381780124894 | K131360 | 000 |
| 10381780124887 | K131360 | 000 |
| 10381780124870 | K131360 | 000 |
| 10381780124863 | K131360 | 000 |
| 10381780124856 | K131360 | 000 |
| 10381780124849 | K131360 | 000 |
| 10381780124832 | K131360 | 000 |
| 10381780124825 | K131360 | 000 |
| 10381780124818 | K131360 | 000 |
| M269TRL1006L011 | K131360 | 000 |