510(k) K112965 ยท MBI Fastener, Fixation, Nondegradable, Soft Tissue
NANO SUTURE ANCHOR
| Applicant | Linvatec Corporation D/B/A Conmed Linvatec, Largo FL, US |
| Decision | Substantially Equivalent, Nov 2, 2011 |
| Received | Oct 5, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K112965
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.6 w/ Two #1 (4 metric) Hi-Fi***Sutures***NP262***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical proced Terminated |
MBI | None listed |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture***NP261***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical procedu Terminated |
MBI | None listed |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***Press FT***2.6 w/ One #2 (5 metric) Hi-Fi***Suture, HIP***N2***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical proc Terminated |
MBI | None listed |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.1 w/ Two #0 (3.5 metric) Hi-Fi***Sutures***NP212***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical proc Terminated |
MBI | None listed |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec "***PressFT***2.1 w/ One #2 (5 metric) Hi-Fi***Suture***NP211***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical procedu Terminated |
MBI | None listed |
| Oct 15, 2012 | Linvatec Corp. dba ConMed Linvatec NP211H***2009-02***CONMED LINVATEC 11311 CONCEPT BLVD LARGO, FL 33773-4908 USA***
To reattach soft tissue to bone in orthopedic surgical procedures Terminated |
MBI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.