The following data is part of a premarket notification filed by Conmed Linvatec with the FDA for Conmed Linvatec Sequent Meniscal Repair Device.
| Device ID | K102339 |
| 510k Number | K102339 |
| Device Name: | CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE |
| Classification | Suture, Nonabsorbable, Synthetic, Polyethylene |
| Applicant | CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Contact | Jan Flegeau |
| Correspondent | Jan Flegeau CONMED LINVATEC 11311 CONCEPT BOULEVARD Largo, FL 33773 -4908 |
| Product Code | GAT |
| CFR Regulation Number | 878.5000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-08-18 |
| Decision Date | 2010-11-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20845854036584 | K102339 | 000 |
| 20845854036577 | K102339 | 000 |
| 20845854015466 | K102339 | 000 |