The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Threvo Suture Anchor With Disposable Driver.
Device ID | K050227 |
510k Number | K050227 |
Device Name: | THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER |
Classification | Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Contact | Elizabeth M Paul |
Correspondent | Elizabeth M Paul LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Product Code | MBI |
CFR Regulation Number | 888.3040 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2005-02-01 |
Decision Date | 2005-03-02 |
Summary: | summary |