| Device Classification Name |
fastener, fixation, nondegradable, soft tissue
|
|---|
| 510(K) Number |
K122059 |
|---|
| Models |
72203841,72203842,7223852,7223853,72203854,
72203842,7223855,72203856,
72209844-45,72203848-49,72203857-59,72203864-66
|
| Device Name |
ALL-SUTURE ANCHOR TWIST DRILL FOR ALL-SUTURE ANCHORS INLINE DRILL GUIDE FOR ALL-SUTURE ANCHORS |
|---|
| Applicant |
| SMITH & NEPHEW, INC. |
| 150 minuteman rd. |
|
andover,
MA
01810
|
|
| Contact |
karin desjardins |
| Regulation Number | 888.3040
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 07/13/2012 |
|---|
| Decision Date | 03/18/2013 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Orthopedic
|
|---|
| Review Advisory Committee |
Orthopedic
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
