The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Conmed Linvatec Paladin, Preloaded With Two #2 Hi-fi Sutures.
| Device ID | K090186 |
| 510k Number | K090186 |
| Device Name: | CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Joy Lovett |
| Correspondent | Joy Lovett LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | MAI |
| CFR Regulation Number | 888.3030 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-26 |
| Decision Date | 2009-04-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854031138 | K090186 | 000 |
| 20845854030650 | K090186 | 000 |