The following data is part of a premarket notification filed by Linvatec Corporation D/b/a Conmed Linvatec with the FDA for Genesys Pressft Suture Anchor.
Device ID | K121890 |
510k Number | K121890 |
Device Name: | GENESYS PRESSFT SUTURE ANCHOR |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo, FL 33773 |
Contact | Lorna K Linville |
Correspondent | Lorna K Linville LINVATEC CORPORATION D/B/A CONMED LINVATEC 11311 Concept Boulevard Largo, FL 33773 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2012-06-28 |
Decision Date | 2012-08-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854051167 | K121890 | 000 |
10845854027899 | K121890 | 000 |
10845854027868 | K121890 | 000 |
30845854027893 | K121890 | 000 |
30845854027862 | K121890 | 000 |
10845854027905 | K121890 | 000 |
10845854027882 | K121890 | 000 |
10845854027875 | K121890 | 000 |
10845854027851 | K121890 | 000 |