The following data is part of a premarket notification filed by Conformis Inc. with the FDA for Triathlon As-1.
| Device ID | K203421 |
| 510k Number | K203421 |
| Device Name: | Triathlon AS-1 |
| Classification | Knee Arthroplasty Implantation System |
| Applicant | Conformis Inc. 600 Technology Park Drive, 4th Floor Billerica, MA 01821 |
| Contact | Mary Kruitwagen |
| Correspondent | Mary Kruitwagen Conformis Inc. 600 Technology Park Drive, 4th Floor Billerica, MA 01821 |
| Product Code | OOG |
| CFR Regulation Number | 888.3560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-20 |
| Decision Date | 2021-04-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| M5726556C012011 | K203421 | 000 |
| M5726556C004011 | K203421 | 000 |
| M5726556C005011 | K203421 | 000 |
| M5726556C006011 | K203421 | 000 |
| M5726556C007011 | K203421 | 000 |
| M5726556C008011 | K203421 | 000 |
| M5726556C001011 | K203421 | 000 |
| M5726556C002011 | K203421 | 000 |
| M5726556C011011 | K203421 | 000 |
| M5726556C003011 | K203421 | 000 |