The following data is part of a premarket notification filed by Linvatec Biomaterials, Ltd. with the FDA for 2.4 Smartnail, Models 532416, 532425, 532435, 532445.
| Device ID | K031981 |
| 510k Number | K031981 |
| Device Name: | 2.4 SMARTNAIL, MODELS 532416, 532425, 532435, 532445 |
| Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
| Applicant | LINVATEC BIOMATERIALS, LTD. 1311 CONCEPT BLVD Largo, FL 33773 |
| Contact | Laura Krejci |
| Correspondent | Laura Krejci LINVATEC BIOMATERIALS, LTD. 1311 CONCEPT BLVD 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 | 2003-06-26 |
| Decision Date | 2003-07-25 |
| Summary: | summary |