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 |