The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Super Revo Herculine Suture Anchor.
Device ID | K041713 |
510k Number | K041713 |
Device Name: | SUPER REVO HERCULINE SUTURE ANCHOR |
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 | 2004-06-23 |
Decision Date | 2004-07-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854019822 | K041713 | 000 |
20845854015848 | K041713 | 000 |
20845854042448 | K041713 | 000 |
20845854042431 | K041713 | 000 |