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 |