The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Super Revo Suture Anchor.
Device ID | K003984 |
510k Number | K003984 |
Device Name: | SUPER REVO SUTURE ANCHOR |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Contact | Laura D Seneff |
Correspondent | Laura D Seneff LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Product Code | MAI |
Subsequent Product Code | GAS |
Subsequent Product Code | HWC |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2000-12-26 |
Decision Date | 2001-03-19 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854019815 | K003984 | 000 |
20845854012311 | K003984 | 000 |