The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Conmed Linvatec Bio Mini-revo Suture Anchor, Model C6170cr.
Device ID | K090835 |
510k Number | K090835 |
Device Name: | CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR |
Classification | Fastener, Fixation, Biodegradable, Soft Tissue |
Applicant | LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Contact | Joy Lovett |
Correspondent | Joy Lovett LINVATEC CORP. 11311 CONCEPT BLVD. Largo, FL 33773 -4908 |
Product Code | MAI |
CFR Regulation Number | 888.3030 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-03-27 |
Decision Date | 2009-06-22 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
20845854019808 | K090835 | 000 |