Device Classification Name |
Fastener, Fixation, Nondegradable, Soft Tissue
More FDA Info for this Device |
510(K) Number |
K965111 |
Device Name |
Fastener, Fixation, Nondegradable, Soft Tissue |
Applicant |
R. THOMAS GROTZ, M.D., INC.
530 BUSH STREET, 10TH FLOOR
SAN FRANCISCO, CA 94108 US
Other 510(k) Applications for this Company
|
Contact |
R. THOMAS GROTZ
Other 510(k) Applications for this Contact |
Regulation Number |
888.3040
More FDA Info for this Regulation Number |
Classification Product Code |
MBI
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/20/1996 |
Decision Date |
02/18/1997 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
OR - Orthopedic |
Review Advisory Committee |
OR - Orthopedic |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|