Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
510(k) Number |
K984200 |
Device Name |
STABILIZER SOFT TISSUE ANCHOR, 5 AND 8MM; ANCHOR INSERTER, 5 AND 8MM; STABILIZER DRILL, 5 AND 8MM, NONSTERILE; STABILIZE |
Applicant |
R. THOMAS GROTZ, M.D., INC. |
530 BUSH STREET, 10TH FLOOR |
SAN FRANCISCO,
CA
94108
|
|
Applicant Contact |
R. THOMAS GROTZ |
Correspondent |
R. THOMAS GROTZ, M.D., INC. |
530 BUSH STREET, 10TH FLOOR |
SAN FRANCISCO,
CA
94108
|
|
Correspondent Contact |
R. THOMAS GROTZ |
Regulation Number | 888.3040
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/24/1998 |
Decision Date | 01/21/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Orthopedic
|
510k Review Panel |
Orthopedic
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|