The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Biobutton.
| Device ID | K990194 |
| 510k Number | K990194 |
| Device Name: | BIOBUTTON |
| Classification | Screw, Fixation, Bone |
| Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Contact | Carol A Weideman |
| Correspondent | Carol A Weideman LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
| Product Code | HWC |
| CFR Regulation Number | 888.3040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-01-21 |
| Decision Date | 1999-09-17 |
| Summary: | summary |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() BIOBUTTON 88900824 not registered Live/Pending |
BioIntelliSense, Inc. 2020-05-05 |
![]() BIOBUTTON 76454467 not registered Dead/Abandoned |
LINVATEC CORPORATION 2002-09-27 |
![]() BIOBUTTON 75638583 not registered Dead/Abandoned |
LINVATEC CORPORATION 1999-02-11 |