The following data is part of a premarket notification filed by Ascension Orthopedics with the FDA for Integra Salto Total Ankle System.
| Device ID | K182878 |
| 510k Number | K182878 |
| Device Name: | Integra Salto Total Ankle System |
| Classification | Prosthesis, Ankle, Semi-constrained, Cemented, Metal/polymer |
| Applicant | Ascension Orthopedics 11101 Metric Blvd. Austin, TX 78758 |
| Contact | Divya Savant |
| Correspondent | Divya Savant Integra LifeSciences Corporation 311 Enterprise Drive Plainsboro, NJ 08536 |
| Product Code | HSN |
| CFR Regulation Number | 888.3110 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-15 |
| Decision Date | 2018-12-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00885556832363 | K182878 | 000 |
| 00885556832356 | K182878 | 000 |
| 00885556832349 | K182878 | 000 |
| 00885556832332 | K182878 | 000 |
| 00885556832325 | K182878 | 000 |
| 00885556832318 | K182878 | 000 |
| 00885556832301 | K182878 | 000 |
| 00885556832295 | K182878 | 000 |
| 00885556832257 | K182878 | 000 |